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[]
[]
[{"$nulls":6},"Standard Pharmaceutical Product and Medical Device Information (Rx Product Only)"]
[null,null,"Version 2021",{"$nulls":11},"Introduction Type:",null,null,"New Item",{"$nulls":7},"x","Final Version",null,null,"Date:","2021-12-20"]
[]
[null,"PRODUCT INFORMATION",{"$nulls":21},"SPECIAL HANDLING AND STORAGE REQUIREMENTS*"]
[]
[null,null,"Company Name:  ",null,null,"ViiV Healthcare",{"$nulls":9},"Application:",null,null,"NDA",{"$nulls":5},"a. Temperature – Indicate the USP temperature range for this product."]
[null,null,null,"Application Number for NDA/ANDA/BLA (drug); PMA/510(k)(med device):",{"$nulls":7},"215499",{"$nulls":13},"Temperature Range"]
[null,null,null,"Medical Device Class, if applicable:"]
[null,null,"DUNS:",null,null,"167380711",{"$nulls":19},"Other Temperature Range Requirement",null,null,"4°C to 30°C (39°F to 86°F)"]
[null,null,"Proprietary Name (If Applicable) and Established Name:  ",{"$nulls":4},"APRETUDE 600 mg/3 mL Kit",{"$nulls":17},"         (write in)"]
[null,null,null,"Selling Unit NDC:",null,"49702-264-23",null,"Unit of Use NDC:",{"$nulls":7},"UPC:","3 49702-264-23 6",{"$nulls":8},"Notes",null,null,"Exposure up to 30°C permitted. Do not freeze."]
[{"$nulls":4},"UDI",{"$nulls":4},"CVX Code:",{"$nulls":4},"MVX Code:"]
[]
[null,null,"Description:   ",null,null,"cabotegravir extended-release injectable suspension, for intramuscular use",{"$nulls":19},"Is this product to be shipped to customers on ice?",{"$nulls":4},"No"]
[{"$nulls":25},"Is this product to be shipped to customers on dry ice? ",{"$nulls":4},"No"]
[null,null,null,"Active Ingredient(s):",null,null,"cabotegravir"]
[null,null," ",{"$nulls":21},"b. Contact for temperature excursion questions:"]
[null,null,"URL for Additional Product Information:  ",null,null,null,"www.viivhealthcare.com",{"$nulls":18},"Name:",null,null,"GSK Pharma Service Center"]
[null,null,"Address: ",null,null,"Five Moore Drive",{"$nulls":7},"Address 2:",{"$nulls":11},"Number:",null,null,"1-800-877-1158"]
[null,null,"City:  ",null,null,"Research Triangle Park",{"$nulls":6},"State:",null,"NC",null,"Zip:",null,"27709",{"$nulls":6},"Group E-mail:",null,null,"Customer-Satisfaction@gsk.com"]
[null,null,"Key Contact: ",null,null,"GSK Customer Service",{"$nulls":6},"Email:",null,"customer-satisfaction@gsk.com"]
[null,null,"Phone Number:",null,null,"1-800-877-1158",{"$nulls":6},"Fax:",null,"215-599-9947",{"$nulls":9},"c. Special regulations for product in any states?",{"$nulls":5},"No"]
[null,null,"Product Therapeutic Classification:",{"$nulls":22},"Special returns requirements for this product? ",{"$nulls":4},"No"]
[]
[null,null,"ADDITIONAL PRODUCT INFORMATION",{"$nulls":11},"PRODUCT DESCRIPTION INFORMATION",{"$nulls":9},"d. Store product (unit of sale) upright?",{"$nulls":5},"No"]
[]
[null,null,null,"The product is?",{"$nulls":5},"Is the Product…       ","Direct-Ship Only",{"$nulls":14},"Protect product (unit of sale) from light? ",{"$nulls":4},"No"]
[null,null,null,"  a legend device?",null,null,"No",null,null,"Is the Product…       ","Neither",{"$nulls":4},"Size:",null,"3 mL kit",{"$nulls":6},"e. Shelf life:  ",{"$nulls":5},36,"Months"]
[null,null,null,"  if yes, enter class #",{"$nulls":5},"Orphan Drug Status",{"$nulls":15},"Initial shelf life at launch (if different):",{"$nulls":5},"Months"]
[null,null,null,"  a product kit?",null,null,"Yes",{"$nulls":8},"Strength:",null,"600-mg"]
[null,null,null,"  if yes, list NDCs of",null,"Kit contains:\n- One single-dose vial of cabotegravir 600 mg/3 mL (200 mg/mL)\n- One vial adapter\n- One syringe\n- One injection needle (23-gauge, 1½ inch)",null,null,null,"FDA Approval Status",{"$nulls":13},"ORDER INFORMATION"]
[null,null,null,"    component parts",{"$nulls":11},"Dosage Form:",null,"extended-release injectable suspension"]
[null,null,null,"  reverse numbered?",null,null,"No",{"$nulls":18},"Unit of Sale",null,null,"What is the NDC selling unit?\n"]
[null,null,null,"  co-licensed?",null,null,"No",null,null,"Allergens Present",{"$nulls":16},"Bottle",null,"1 kit"]
[null,null,null,"  latex-free?",null,null,"Yes",{"$nulls":8},"Product Shape:",{"$nulls":10},"Box/Carton",null," (Write-in, e.g. 1 Box of 10 Vials)"]
[null,null,null,"  preservative-free?",null,null,"Yes",{"$nulls":19},"Ampule"]
[null,null,null,"  correctional institution block?",null,null,"No",{"$nulls":8},"Product Color:",null,"white to light pink",{"$nulls":8},"Glass",null,"Minimum order quantity?",null,null,"Yes"]
[null,null,null,"  opioid?",null,null,"No",{"$nulls":19},"Tube"]
[null,null,null,"  Cannabinoid?",null,null,"No",null,null,"Country of Origin","Great Britain",{"$nulls":4},"Product Imprint:",{"$nulls":10},"Vial Liquid Sgl"]
[null,null,null,"If Unit Dose, is item bar coded to unit dose for hospital scanning?",{"$nulls":22},"Vial Liquid Multi",null,"If Yes, how many of which package type? "]
[{"$nulls":9},"Is this product covered under the Trade Agreements Act (TAA)?",{"$nulls":16},"Vial Powder Sql",null,"1 kit","Each"]
[null,null,null,"If Unit Dose, indicate NDC here: ",{"$nulls":8},"Yes",{"$nulls":13},"Vial Power Multi",null,null,"Inner/Carton/Pack"]
[{"$nulls":25},"x","Other: Write In",null,null,"Case"]
[]
[null,"FOR GENERIC DRUG PRODUCTS",{"$nulls":24},"1 kit"]
[]
[{"$nulls":13},"  Authorized Generic",null,null,"*If Authorized Generic, other section fields are not applicable",{"$nulls":6},"PHARMACY ORDER / BILL UNIT"]
[]
[null,null,"I. Orange Book Rating:",{"$nulls":21},"Rec. sell unit to customer?\n",null,null,null,"Rx billing unit to pharmacy:"]
[null,null,"II. Generic Equivalent to What Brand?:",{"$nulls":21},"1 kit",null,null,null,"1 kit"," Each"]
[{"$nulls":24}," (Write-in, e.g. 1 Vial)",{"$nulls":4}," Gram"]
[null,"DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATION",{"$nulls":27}," Milliliter"]
[]
[null,null,"Does supplier meet DSCSA definition of manufacturer?",{"$nulls":4},"Yes",{"$nulls":4},"GLN:",{"$nulls":10},"ITEM AND PACKING INFORMATION"]
[null,null,"Is product exempt from DSCSA?",null,null,null,"No"]
[]
[null,null,null,"If yes, select exemption:",{"$nulls":8},"GCP:",{"$nulls":13},"Weight Lbs.","Dimensions (US msmts.)",null,null,"Volume (Cube) ","Saleable # Pieces"]
[null,null,null,"Other exemption - Write in:",{"$nulls":7}," ",{"$nulls":15},"Depth","Width","Height"]
[null,null,"Is product repackaged? ",null,null,null,"No",{"$nulls":5},"If yes, was original product purchased direct from mfr? ",{"$nulls":11},"Item/Each:",null," 0.168 lbs","5.63\"","1.732\"","5.197\"","0.0293 cu ft","1 kit"]
[null,null,"Is product sold by manufacturer's exclusive distributor?",{"$nulls":4},"No"]
[null,null,"Has FDA granted waiver/exception/exemption for product?",{"$nulls":9},"Provide source manufacturer for repackaged product",{"$nulls":11},"Box/Carton/Bundle/ Inner Pack:"]
[null,null,null,"If yes, attach documentation from FDA."]
[{"$nulls":24},"Case:",null," 3.369 lbs","10.866\"","9.094\"","11.575\"","0.662 cu ft",20]
[null,null,"GTIN AND HIBCC PRODUCT INFORMATION"]
[{"$nulls":24},"Pallet:"]
[null,null,null,"Saleable Unit of Measure",null,null,"Saleable Quantity",null,null,"HIBCC",null,null,null,"GTIN-14",{"$nulls":4},"Unit of Use GTIN-14"]
[null,null,null,"x","Item/Each",null,1,{"$nulls":6},"00349702264236"]
[null," ",null,null,"Box/Carton/Bundle/Inner Pack",{"$nulls":18},"COST INFORMATION",{"$nulls":4},"WHOLESALER USE ONLY:"]
[null,null,null,"x","Case",null,20,{"$nulls":6},"20349702264230"]
[{"$nulls":4},"Pallet",{"$nulls":19},"Regular Cost Per Unit of Sale ($) ",null,null,null,"Vendor #:"]
[{"$nulls":24},"Invoice Cost (WAC) ($) ",null,null,3700,"Whsl. Code #:  "]
[{"$nulls":28},"Fineline Code: "]
[{"$nulls":24},"As of date:",null,"2021-12-21"]
[]
[]
[]
[null,null,"Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE."]
[null,null,"*Please provide any additional information on page 2.",{"$nulls":11},"See new p. 3 for Designated Drop Ship Only.",{"$nulls":10},"Signature:"]

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[]
[]
[null,null,"Standard Pharmaceutical Product and Medical Device Information (Rx Product Only)"]
[null,null,{"$f":"'Blank Template P1'!C4:E4","v":"Version 2021"},{"$nulls":8},"For Designated Drop Ship Only Products, Please Use Page 3"]
[]
[null," MATERIAL HAZARD CLASSIFICATION and TRANSPORTATION"]
[]
[null,null," Is this product (check all that apply):"]
[null,null,null,"a. Cytotoxic?     ",{"$nulls":9},"No",null,null,"SDS Hazard Classification"]
[null,null,null,"b. CA Prop. 65 Carcinogen or Reproductive Toxicant?"]
[{"$nulls":4},"Is the product a CA Prop 65 carcinogen?",{"$nulls":8},"No",null,null,null,"x"," Organic",null,null,null," Corrosive"]
[{"$nulls":4},"Is the product a CA Prop 65 reproductive toxicant?",{"$nulls":8},"No",{"$nulls":4}," Inorganic",null,null,null," Oxidizer"]
[{"$nulls":4},"Does the product label bear a CA Prop 65 warning?",{"$nulls":8},"No",{"$nulls":4}," Steroid/Androgen",null,null,null," Contact Hazard"]
[]
[null,null,null,"c. Contact Hazard?",{"$nulls":9},"No",null,null,null,"Does the product have an Aerosol class? If yes, identify NFPA Storage Level:",{"$nulls":4},"No"]
[null,null,null,"d. Does this product require special clean-up instructions?",{"$nulls":9},"No",null," "]
[null,null,null," ",null,"(If yes, attach SDS with special instructions.)",{"$nulls":11},"NFPA Storage Level:  "]
[null,null,null,"e. Does the product contain DEHP?",{"$nulls":9},"No"]
[]
[null,null,"Is this product regulated for shipment by DOT?",{"$nulls":10},"Yes",null,null,null,"Is the product a NIOSH hazardous drug?",{"$nulls":4},"No"]
[null,null,null,"(if yes, answer a-e below and provide SDS)",{"$nulls":14},"If yes, indicate which:"]
[null,null,null,"a. UN/Identification Number",{"$nulls":5},"UN3082"]
[null,null,null,"b. Proper Shipping Name",{"$nulls":5},"Environmentally hazardous substances, liquid, n.o.s. (cabotegravir)"]
[null,null,null,"c. DOT Hazard Class",{"$nulls":5},"9",{"$nulls":6},"Hazardous Waste Identification"]
[null,null,null,"d. Packing Group",{"$nulls":5},"III"]
[null,null,null,"e. Inhalation Hazard?",{"$nulls":9},"Yes",null,null,null,"EPA Hazardous Waste Code:",{"$nulls":8},"Waste Characteristics"]
[]
[null,null,"Is this product regulated for shipment by IATA?",{"$nulls":10},"Yes"]
[null,null,null,"(if yes, answer a-e below and provide SDS)",{"$nulls":11},"REMS or REGISTRY RESTRICTIONS  "]
[null,null,null,"a. UN/Identification Number",{"$nulls":5},"UN3082"]
[null,null,null,"b. Proper Shipping Name",{"$nulls":5},"Environmentally hazardous substances, liquid, n.o.s. (cabotegravir)",{"$nulls":6},"Is there a REMS on this product? ",{"$nulls":5},"No"]
[null,null,null,"c. DOT Hazard Class",{"$nulls":5},"9",{"$nulls":7},"If Yes, is it managed with a pharmacy registry?"]
[null,null,null,"d. Packing Group",{"$nulls":5},"III",{"$nulls":8},"Website URL:"]
[null,null,null,"e. Inhalation Hazard?",{"$nulls":9},"Yes"]
[]
[null,null,"Is the product restricted for air shipment?  If so, indicate restriction:",{"$nulls":10},"Yes",null,null,"Med Guide Required",{"$nulls":5},"No"]
[{"$nulls":4}," Passenger",{"$nulls":11},"Limited Distribution Requirement",{"$nulls":5},"No"]
[{"$nulls":4}," Cargo",{"$nulls":11},"Comments / Details: (For example, iPledge program?)"]
[null,null,null,"x"," Passenger & Cargo"]
[]
[null,null,"Is this a reportable quantity?",{"$nulls":5},"No",{"$nulls":6}," ","REMS:",{"$nulls":5},"No"]
[null,null,null,"RQ Threshold:",{"$nulls":14},"REMS Program Manager Name:",{"$nulls":8},"Phone:"]
[null,null,"Is this a marine pollutant?",{"$nulls":5},"Yes",{"$nulls":9},"Supplier Manages REMS registry exclusively:"]
[null,null,"Is this product shipped utilizing an authorized DOT exception or Special Permit? ",{"$nulls":15},"     Wholesale distributor support:"]
[null,null,null,"Yes",null,"  (if yes, identify method below)",{"$nulls":12},"     Provider Name:",{"$nulls":8},"DEA #:"]
[{"$nulls":4}," Limited Quantity",{"$nulls":13},"     Site Enrollment Number assigned",{"$nulls":8},"NCPDP#:"]
[{"$nulls":4}," Consumer Commodity, ORM-D",{"$nulls":13},"     by Supplier:",{"$nulls":8},"NPI #:"]
[{"$nulls":4}," Small Quantity (49 CFR 173.4)"]
[{"$nulls":4}," Special Permit; DOT-SP",{"$nulls":13},"Comments "]
[null,null,null,"x"," Special Provision (listed in Column 7 of 49 CFR 172.101); "]
[{"$nulls":4}," SP#","49 CFR 171.4 (2) (c) and IATA Provision A197",{"$nulls":10},"Registry:",{"$nulls":5},"No"]
[{"$nulls":18},"Registry Program Contact Name:",{"$nulls":8},"Phone:"]
[null,"ADD'L STORAGE INFORMATION",{"$nulls":16},"Comments "]
[]
[null,null,"Is the Product…       "]
[null,null,"  Controlled Substance?",{"$nulls":5},"No",null,"  Controlled Substance Code",{"$nulls":4},"RETURN INSTRUCTIONS"]
[null,null,"  Controlled by State(s)?",{"$nulls":5},"No",null,"  Listed Chemical (List I or II)"]
[null,null,"  ARCOS Reportable?",{"$nulls":5},"No",null,null,"If yes, indicate which:",null,null," ",null,"Contact tel. # if product received damaged:",{"$nulls":5},"1-800-877-1158"]
[null,null,"  Schedule No.",{"$nulls":8},"Is it a scheduled listed chemical product?:",{"$nulls":5},"Is product returnable for credit:",{"$nulls":4},"Yes"]
[]
[null,"CLASS OF TRADE RESTRICTION: ",{"$nulls":16},"URL/Link to returns policy:","www.gsk-ecs.com"]
[]
[null,null,"No restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices",{"$nulls":10},"No"]
[]
[null,null,"Restricted to retail pharmacy only:",{"$nulls":10},"No",null,null,"Special regulations or returns requirements for this product in certain states?"]
[]
[null,null,"Restricted to hospital, clinics, and physician offices only:",{"$nulls":10},"Yes",{"$nulls":8},"No"]
[null,null,"Restricted from US territories? (explain in comments)",{"$nulls":10},"No",null,null,"If so, which states? Other requirements? Comments?"]
[]
[null,null,"Comments:"]
[]
[]
[]
[null,"MISCELLANEOUS NOTES and/or Image of Product Barcode:"]
[]
[]
[]
[]
[null,"Release DATE"]

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[]
[]
[null,null,"Standard Pharmaceutical Product and Medical Device Information (Rx Product Only)"]
[null,null,{"$f":"'Blank Template P1'!C4:E4","v":"Version 2021"},null,null,null,"FOR DESIGNATED DROP SHIP PRODUCT ONLY - if not a designated drop ship, do not complete."]
[]
[null,"Order Method for Designated  Drop Ship Product",{"$nulls":9},"Standard Order Receipt and Processing"]
[]
[null,null,"Purchase orders may be accepted by:",{"$nulls":9},"Purchase order daily receipt cut off time by supplier"]
[null,null,"a.","EDI",{"$nulls":8},"Cut off time:"]
[null,null,"b.","Autofax",null,null,null," Fax Number:"]
[null,null,"c.","Fax",null,null,null," Fax Number:",{"$nulls":4},"Shipping lead time of PO:",{"$nulls":4},"  Hours",null,null,"  Days"]
[null,null,"d.","Phone only",null,null,null," Phone No.:"]
[null,null,"e.","Supplier Web Site only",null,null,null," Site Address:",{"$nulls":4},"Ships same day for next day receipt:"]
[null,null,"Minimum Order Quantity:",{"$nulls":9},"Ships for second day receipt:"]
[null,null,"Supplier's Customer Service Number:",{"$nulls":9},"Ships regular ground for 3-10 days receipt:"]
[null,null,"Contracted 3PL company / contact #:",null,null,null,"Name:"]
[{"$nulls":6},"Phone:"]
[]
[null,"Expedited Freight Charges or Other Designated Drop Ship Fees:",{"$nulls":9},"Overnight and Priority Overnight PO Processing "]
[]
[null,null,"Expedited freight fees billed with each order:",{"$nulls":9},"Overnight receipt available:"]
[]
[null,null,"Drop Ship service fee billed with each order:",{"$nulls":9},"PO Receipt cut off time:"]
[]
[null,null,"Drop Ship miscellaneous fees billed:",{"$nulls":11},"Days of week overnight is available:",{"$nulls":4}," Monday"]
[null,null,"Comments:",{"$nulls":16}," Tuesday"]
[" ",{"$nulls":18}," Wednesday"]
[{"$nulls":19}," Thursday"]
[{"$nulls":19}," Friday"]
[]
[{"$nulls":12},"Priority Overnight receipt available:"]
[]
[null,"Class of Trade Restriction:",{"$nulls":13},"PO Receipt Cut off time:"]
[]
[null,null,"No restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices",{"$nulls":9},"Saturday Overnight receipt available:"]
[null,null,"Restricted to retail pharmacy only:",{"$nulls":9},"Order receipt method:",null,null,"PO Receipt Cut off time:"]
[null,null,"Restricted to hospital, clinics, and physician offices only:",{"$nulls":12},"Phone:",null," Phone #:"]
[null,null,"Restricted from US territories? (explain in comments)",{"$nulls":12},"Fax:",null," Fax #:"]
[null,null,"Comments:",{"$nulls":12},"EDI:"]
[{"$nulls":12},"Overnight Fees apply:"]
[{"$nulls":12},"Other fees apply:"]
[]
[null," Other Data Information Required to Process PO:",{"$nulls":9},"Return Instructions"]
[]
[null,null,"Patient Procedure Date:",{"$nulls":9},"Contact # if product is received damaged:"]
[null,null,"Physician Name:",{"$nulls":9},"Is product returnable for credit:"]
[null,null,"Physician/Clinic Phone #",{"$nulls":9},"URL/Link to returns policy:"]
[null,null,"Physician State License #"]
[null,null,"Physician/Clinic DEA #:",{"$nulls":9},"Special regulations or returns requirements for this product in certain states?"]
[null,null,"Physician/Clinic Specialty:",{"$nulls":10},"If so, which states? Other requirements? Comments?"]
[]
[null,"Miscellaneous Notes:"]
[]
[]
[]
[]
[{"$nulls":11},"ADDITIONAL INFORMATION"]
[]
[{"$nulls":12},"Is product order for scheduled patient procedure?"]
[{"$nulls":12},"Is product order for restocking purposes?"]

{"sheet":"Data Validation","index":3,"n_rows":14,"n_cols":22,"rows_kept":14,"cut":false,"hidden":true,"merged":[]}
[]
[]
[null,"Introduction Type","Application","Yes/No","Yes/No*","Product Type","Product Exemption","Item Type","Aerosol Class","Units/Dollars","Time Zone","Page Creation Selection","Page Removal Selection","Form Selection","Temperature Ranges","NIOSH Hazardous Drug","Listed Chemical","Orphan Drug Status","FDA Approval Status","Schedule No.","Waste Characteristics","Medical Device Class"]
[null,"New Item","NDA","Yes","*Yes","Direct-Ship Only","Blood, blood components intended for transfusion","Unit Dose","Level 1","Units","Eastern","All Pages","All Pages","Blank Template","Frozen – less than -25 C (< -13° F)","Group 1 items (antineoplastic)","Ephedrine","Designated","Approved for Orphan Indication",2,"D001","Class I with exemptions"]
[null,"Promotion/Deal","ANDA","No","No","Drop-Ship Only","Radioactive drugs, radioactive biologics","Unit of Use","Level 2","Dollars","Central","Only Pages 1 and 2","Only Page 3",null,"Freezer – between -25 and -10 C (-13° – 14° F)","Group 2 items (non-antineoplastic that meets a hazard criterion)","Pseudoephedrine","Approved",null,"2N","D002","Class I without exemptions"]
[null,"Open Stock","BLA",null,null,"Direct And Drop-Ship","Imaging drugs","Neither","Level 3",null,"Pacific",null,null,null,"Cold – between 2 and 8 C (36° – 46° F)","Group 3 items (primarily adverse reproductive effects)","Phenylpropanolamine",null,null,3,"D003","Class II with exemptions"]
[null,"Post Launch Change","Med Device",null,null,null,"Certain intravenous products ",{"$nulls":7},"Cool – between 8 and 15 C (46° – 59° F)",null,"Iodine (≥2.2%)",null,null,"3N","D004","Class II without exemptions"]
[{"$nulls":6},"Medical gas",{"$nulls":7},"Controlled Room – between 20 and 25 C (68° – 77° F)",{"$nulls":4},4,null,"Class III PMA"]
[{"$nulls":6},"Compounded drugs",{"$nulls":7},"Avoid Excessive Heat – above 40 C (>104° F)",{"$nulls":4},5,null,"Class III Pre-PMA"]
[{"$nulls":6},"Certain medical convenience kits, combo products"]
[{"$nulls":6},"Sterile water, products intended for irrigation"]
[{"$nulls":6},"Homeopathic drugs"]
[{"$nulls":6},"Medical device"]
[{"$nulls":6},"Other exemption:  (Write in)"]