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[]
[]
[{"$nulls":6},"Standard Pharmaceutical Product Information (Rx Product Only)"]
[null,"© August 2014",{"$nulls":12},"Introduction Type:",null,null,"New Item",{"$nulls":7},"x","Final Version",null,null,"Date:","2018-05-22"]
[]
[null,"PRODUCT INFORMATION",{"$nulls":21},"SPECIAL HANDLING AND STORAGE REQUIREMENTS*"]
[]
[null,null,"Company Name:  ",null,null,"GlaxoSmithKline",{"$nulls":9},"Application:",null,null,"NDA",{"$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):",{"$nulls":7},"205625",{"$nulls":13},"Temperature Range",null,null,"Controlled Room – between 20 and 25 C (68° – 77° F)"]
[]
[null,null,"DUNS:",null,null,"02-729-5585",{"$nulls":19},"Other Temperature Range Requirement"]
[null,null,"Proprietary Name (If Applicable) and Established Name:  ",{"$nulls":4},"Arnuity Ellipta (fluticasone furoate inhalation powder) ",{"$nulls":17},"         (write in)"]
[null,null,null,"Selling Unit NDC:",null,"0173-0888-10",null,"Individual Unit NDC:",{"$nulls":7},"UPC:","3 0173-0888-10 5"]
[{"$nulls":4},"UDI",{"$nulls":4},"CVX Code:",{"$nulls":4},"MVX Code:",{"$nulls":10},"Is this product to be shipped to customers on ice?",{"$nulls":4},"No"]
[]
[null,null,"Description:   ",null,null,"Inhalation powder containing 50 mcg of fluticasone furoate per\nactuation",{"$nulls":19},"Is this product to be shipped to customers on dry ice? ",{"$nulls":4},"No"]
[]
[null,null,null,"Active Ingredient(s):",null,null,"fluticasone furoate 50 mcg",{"$nulls":17},"b. Contact for temperature excursion questions:"]
[null,null," ",{"$nulls":22},"Name:"]
[null,null,"URL for Additional Product Information:  ",null,null,null,"www.arnuity.com",{"$nulls":18},"Number:"]
[null,null,"Address: ",null,null,"Five Moore Drive",{"$nulls":7},"Address 2:",{"$nulls":11},"Group E-mail:"]
[null,null,"City:  ",null,null,"Research Triangle Park",{"$nulls":6},"State:",null,"NC","Zip:",null,null,"27709"]
[null,null,"Key Contact: ",null,null,"GSK Customer Service",{"$nulls":6},"Email:",null,"Customer-Satisfaction@gsk.com",{"$nulls":9},"c. Special regulations for product in any states?",{"$nulls":5},"No"]
[null,null,"Phone Number:",null,null,"1-800-877-1158",{"$nulls":6},"Fax:",null,"215-599-9947",{"$nulls":10},"Special returns requirements for this product? ",{"$nulls":4},"No"]
[null,null,"Product Therapeutic Classification:"]
[{"$nulls":24},"d. Store product (unit of sale) upright?",{"$nulls":5},"No"]
[null,null,"ADDITIONAL PRODUCT INFORMATION",{"$nulls":8},"PRODUCT DESCRIPTION INFORMATION",{"$nulls":13},"Protect product (unit of sale) from light? ",{"$nulls":4},"No"]
[]
[null,null,null,"Is the Product…       ",{"$nulls":20},"e. Shelf life:  ",{"$nulls":5},24,"Months"]
[null,null,null,"  a legend device?",null,null,null,"No",{"$nulls":4},"Size:",null,null,"30 blisters (30 inhalations)",{"$nulls":9},"Initial shelf life at launch (if different):",{"$nulls":5},"Months"]
[null,null,null,"  reverse numbered?",null,null,null,"No"]
[null,null,null,"  co-licensed?",null,null,null,"No",{"$nulls":4},"Strength:",null,null,"50 mcg",{"$nulls":7},"ORDER INFORMATION"]
[null,null,null,"Is the Product…       ",null,null,"Direct-Ship Only"]
[null,null,null,"Is the Product…       ",null,null,"Unit of Use",{"$nulls":5},"Dosage Form:",null,null,"Dry powder for oral inhalation",{"$nulls":9},"Unit of Sale",null,null,"What is the NDC selling unit?\n"]
[{"$nulls":26},"Bottle",null,"0173-0888-10 (1 Box with 30 blisters)"]
[null,null,null,"If Unit Dose, is item bar coded to unit dose for hospital scanning? ",{"$nulls":21},"x","Box/Carton",null," (Write-in, e.g. 1 Box of 10 Vials)"]
[{"$nulls":12},"Product Shape:",null,null,"Ellipta Inhaler with 30 blisters",{"$nulls":10},"Ampule"]
[null,null,null,"If Unit Dose NDC, indicate NDC here: ",{"$nulls":22},"Glass",null,"Minimum order quantity?",null,null,"Yes"]
[{"$nulls":12},"Product Color:",null,null,"light grey and orange plastic inhaler",{"$nulls":10},"Tube"]
[null,null,null,"Country of Origin",null,null,"Singapore",{"$nulls":19},"Vial Liquid Sgl"]
[null,null,null,"Is this product covered under the Trade Agreements Act (TAA)?",{"$nulls":8},"Product Imprint:",null,null,"Arnuity Ellipta 50 mcg",{"$nulls":10},"Vial Liquid Multi",null,"If Yes, how many of which package type? "]
[{"$nulls":7},"Yes",{"$nulls":18},"Vial Powder Sql",null,1,"Each"]
[{"$nulls":26},"Vial Power Multi",null,null,"Inner/Carton/Pack"]
[{"$nulls":26},"Other: Write In",null,null,"Case"]
[null,"FOR GENERIC DRUG PRODUCTS"]
[]
[{"$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?:",{"$nulls":21},"0173-0888-10 (1 Box with 30 blisters)",null,null,null,"x"," Each"]
[{"$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?",{"$nulls":4},"Yes",null,null,null,"GLN:",{"$nulls":11},"ITEM AND PACKING INFORMATION"]
[null,null,"Is product exempt from DSCSA?",null,null,null,"No"]
[null,null,null,"If yes, select exemption:",{"$nulls":22},"Weight Lbs.","Dimensions (US msmts.)",null,null,"Volume (Cube) ","# Pieces:"]
[null,null,null,"Other exemption - Write in:",{"$nulls":14}," ",{"$nulls":8},"Depth","Height","Width"]
[null,null,"Is product repackaged? ",null,null,null,"No",{"$nulls":4},"If Yes, was original product purchased direct from mfr? ",{"$nulls":12},"Item:"]
[null,null,"Is product sold by manufacturer's exclusive distributor?",{"$nulls":4},"No"]
[null,null,"Has FDA granted waiver/exception/exemption for product?",{"$nulls":4},"No",null,null,null,"If yes, attach documentation from FDA.",{"$nulls":12},"Box/Carton/Bundle/ Inner Pack:",null,0.25,"3.58\"","4.13\"","1.81\"","0.15 cu ft",1]
[]
[null,null,"GTIN PRODUCT INFORMATION",{"$nulls":21},"Case:",null,6.73,"11.22\"","7.48\"","8.78\"","0.43 cu ft",24]
[{"$nulls":10},"Saleable Unit"]
[{"$nulls":7},"Level",{"$nulls":8},"Quantity",null,"GTIN-14",{"$nulls":5},"Pallet:"]
[null,null,null,"Serialized? ",null,"Yes",null,null,null,"Item",null,null,null," 2D",null," Linear"]
[null,null,null,"If not, when? ",{"$nulls":5},"Box/Carton/Bundle/Inner Pack",null,null,null," 2D",null," Linear",{"$nulls":8},"UPC:",null,"Case:"]
[null," ",null,"Items aggregated?",null,"Yes",null,"x",null,"Case","x",null,"x"," 2D",null," Linear",24,null,"20301730888109",{"$nulls":7},"Carton:"]
[{"$nulls":9},"Pallet",null,null,null," 2D",null," Linear"]
[{"$nulls":7},"x",null,"Box/Carton/Bundle/Inner Pack","x",null,"x"," 2D",null," Linear",1,null,"00301730888105",{"$nulls":4},"COST INFORMATION",{"$nulls":4},"WHOLESALER USE ONLY:"]
[{"$nulls":13}," 2D",null," Linear"]
[{"$nulls":13}," 2D",null," Linear",{"$nulls":8},"Regular Cost Per Unit of Sale ($) ",null,null,null,"Vendor #:"]
[{"$nulls":13}," 2D",null," Linear",{"$nulls":8},"Invoice Cost (WAC) ($) ",null,null,168.5,"Whsl. Code #:  "]
[{"$nulls":24},"Federal Excise Tax Per Unit of Sale",null,null,null,"Fineline Code: "]
[{"$nulls":24},"As of date:",null,"2018-05-23"]
[]
[]
[null,null,"Attach copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF PRODUCT PACKAGING and BARCODE."]
[null,null,"*Please provide any additional information on page 2.",{"$nulls":11},"See new p. 3 for Designated Drop Ship Only.",{"$nulls":10},"Signature:"]

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[]
[]
[null,null,"Standard Pharmaceutical Product Information (Page 2)"]
[null,null,"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?     ",{"$nulls":7},"No",null,null,"SDS Hazard Classification"]
[null,null,null,"b. CA Prop. 65 Carcinogen or Reproductive Toxicant?"]
[{"$nulls":4},"Is the product a CA Prop 65 carcinogen?",{"$nulls":6},"No",null,null,null,"x"," Organic",null,null,null," Corrosive"]
[{"$nulls":4},"Is the product a CA Prop 65 reproductive toxicant?",{"$nulls":6},"No",{"$nulls":4}," Inorganic",null,null,null," Oxidizer"]
[{"$nulls":4},"Does the product label bear a CA Prop 65 warning?",{"$nulls":6},"No",{"$nulls":4}," Steroid/Androgen",null,null,null," Contact Hazard"]
[]
[null,null,null,"c. Contact Hazard?",{"$nulls":7},"No",{"$nulls":4}," Aerosol Class; Identify NFPA Storage Level:  "]
[null,null,null,"d. Does this product require special clean-up instructions?",{"$nulls":7},"No",null," "]
[null,null,null," ",null,"(If yes, attach SDS with special instructions.)",{"$nulls":9},"Is the product a NIOSH hazardous drug?"]
[null,null,null,"e. Does the product contain DEHP?",{"$nulls":7},"No",{"$nulls":4},"If yes, indicate which:"]
[]
[null,null,"Is this product regulated for shipment by DOT or IATA?",{"$nulls":8},"No"]
[null,null,null,"(if yes, answer a-e below and provide SDS)"]
[null,null,null,"a. UN/Identification Number"]
[null,null,null,"b. Proper Shipping Name",{"$nulls":10},"Hazardous Waste Identification"]
[null,null,null,"c. DOT Hazard Class",{"$nulls":10},"EPA Hazardous Waste Code:"]
[null,null,null,"d. Packing Group"]
[null,null,null,"e. Inhalation Hazard?",{"$nulls":7},"No"]
[]
[null,null,"Is the product restricted for air shipment?  If so, indicate restriction:",{"$nulls":10},"REMS or REGISTRY RESTRICTIONS  "]
[{"$nulls":4}," Passenger",{"$nulls":9},"Is there a REMS on this product? ",{"$nulls":5},"No"]
[{"$nulls":4}," Cargo",{"$nulls":10},"If Yes, is it managed with a pharmacy registry?"]
[{"$nulls":4}," Passenger & Cargo",{"$nulls":11},"Website URL:"]
[]
[null,null,"Is this a reportable quantity?",{"$nulls":5},"No",{"$nulls":4}," "]
[null,null,null,"RQ Threshold:",{"$nulls":10},"Comments / Details: (For example, iPledge program?)"]
[null,null,"Is this a marine pollutant?",{"$nulls":5},"No"]
[null,null,"Is this product shipped utilizing an authorized DOT exception or Special Permit? "]
[{"$nulls":5},"  (if yes, identify method below)",{"$nulls":8},"REMS:"]
[{"$nulls":4}," Limited Quantity",{"$nulls":11},"REMS Program Manager Name:",{"$nulls":7},"Phone:"]
[{"$nulls":4}," Consumer Commodity, ORM-D",{"$nulls":11},"Supplier Manages REMS registry exclusively:"]
[{"$nulls":4}," Small Quantity (49 CFR 173.4)",{"$nulls":11},"     Wholesale distributor support:"]
[{"$nulls":4}," Special Permit; DOT-SP",{"$nulls":11},"     Provider Name:"]
[{"$nulls":4}," Special Provision (listed in Column 7 of 49 CFR 172.101); ",{"$nulls":11},"     Site Enrollment Number assigned",{"$nulls":7},"DEA #:"]
[{"$nulls":4}," SP#",{"$nulls":11},"     by Supplier:",{"$nulls":7},"PCPDP #:"]
[{"$nulls":24},"NPI #:"]
[null,"ADD'L STORAGE INFORMATION"]
[null,null,"Is the Product…       ",{"$nulls":11},"Comments "]
[null,null,"  Controlled Substance?",{"$nulls":8},"No"]
[null,null,"  Controlled by State(s)?",{"$nulls":8},"No",null,null,"Registry:"]
[null,null,"  ARCOS Reportable?",{"$nulls":8},"No"," ",null,null,null,"Registry Program Contact Name:",{"$nulls":7},"Phone:"]
[null,null,"  Schedule No. (inc. N for non-narcotic)",{"$nulls":11},"Comments "]
[null,null,"  Controlled Substance Code"]
[null,null,"  Listed Chemical (List I or II)",{"$nulls":10},"RETURN INSTRUCTIONS"]
[null,null,"  ","If yes, indicate which:"]
[null,null,"  ","Is it a scheduled listed chemical product?:",{"$nulls":10},"Contact tel. # if product received damaged:",{"$nulls":5},"1-800-877-1158"]
[]
[null,"CLASS OF TRADE RESTRICTION: ",{"$nulls":13},"Is product returnable for credit:",{"$nulls":4},"Yes"]
[]
[null,null,"No restriction: Select YES if sold to retail pharmacy, hospitals, clinics and physician offices",{"$nulls":8},"No",{"$nulls":4},"URL/Link to returns policy:",null,null,null,"www.gsk-ecs.com"]
[]
[null,null,"Restricted to retail pharmacy only:",{"$nulls":8},"No",null,null,"Special regulations or returns requirements for this product in certain states?",{"$nulls":9},"No"]
[]
[null,null,"Restricted to hospital, clinics, and physician offices only:",{"$nulls":8},"No",null,null,"If so, which states? Other requirements? Comments?"]
[null,null,"Restricted from US territories? (explain in 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 Information (Page 3)"]
[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 #",{"$nulls":9},"URL/Link to returns policy:"]
[null,null,"Physician State License #",{"$nulls":9},"Special regulations or returns requirements for this product in certain states?"]
[null,null,"Physician/Clinic DEA #:",{"$nulls":10},"If so, which states? Other requirements? Comments?"]
[null,null,"Physician/Clinic Specialty:"]
[]
[null,"Miscellaneous Notes:"]
[]
[]
[{"$nulls":11},"ADDITIONAL INFORMATION"]
[]
[{"$nulls":12},"Is product order for scheduled patient procedure?"]
[{"$nulls":12},"Is product order for restocking purposes?"]

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[]
[]
[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"]
[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"]
[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"]
[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,"Post Launch Change","Med Device",null,null,null,"Certain intravenous products ",{"$nulls":7},"Cool – between 8 and 15 C (46° – 59° F)",null,"Iodine (≥2.2%)"]
[{"$nulls":6},"Medical gas",{"$nulls":7},"Controlled Room – between 20 and 25 C (68° – 77° F)"]
[{"$nulls":6},"Compounded drugs",{"$nulls":7},"Avoid Excessive Heat – above 40 C (>104° F)"]
[{"$nulls":6},"Certain medical convenience kits, combo products"]
[{"$nulls":6},"Sterile water, products intended for irrigation"]
[{"$nulls":6},"Homeopathic drugs"]
[{"$nulls":6},"Other exemption:  (Write in)"]