Standard Pharmaceutical Product Information (Rx …

1 Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Final VersionDate:a. Temperature Indicate the USP temperature range for this Number for NDA/ANDA/BLA (drug); PMA/510(k)(med device):Temperature RangeDUNS:Other Temperature Range RequirementProprietary Name (If Applicable) and Established Name: (write in)Selling Unit NDC:UPC:UDICVX Code:Is this Product to be shipped to customers on ice?NoIs this Product to be shipped to customers on dry ice? NoActive Ingredient(s):b. Contact for temperature excursion questions: Name:URL for Additional Product Information : Number:Group E-mail:City: NJKey Contact: c. Special regulations for Product in any states?NoPhone Number:Special returns requirements for this Product ? Product Therapeutic Classification:d. Store Product (unit of sale) upright?

2 NoProtect Product (unit of sale) from light? NoIs the e. Shelf life: 24 Months a legend device?NoInitial shelf life at launch (if different):Months reverse numbered?No co-licensed?NoIs the Is the Unit of SaleXBottleBox/Carton (Write-in, 1 Box of 10 Vials)AmpuleIf Unit Dose NDC, indicate NDC here: GlassMinimum order quantity?YesTubeCountry of OriginVial Liquid SglVial Liquid MultiIf Yes, how many of which package type? Vial Powder SqlEachVial Power MultiInner/Carton/PackOther: Write InX Case Authorized GenericI. Orange Book Rating:Rx billing unit to pharmacy:II. Generic Equivalent to What Brand?:X Each (Write-in, 1 Vial) Gram MilliliterDoes supplier meet DSCSA definition of manufacturer?GLN:Is Product exempt from DSCSA?If yes, select exemption:Other exemption - Write in: Depth Height WidthIs Product repackaged?

3 Is Product sold by manufacturer's exclusive distributor?Has FDA granted waiver/exception/exemption for Product ?If yes, attach documentation from GTIN-14 Serialized? NoXItemXX 2D Linear1If not, when? 1/1/2018 Box/Carton/Bundle/Inner Pack 2D LinearCase: Items aggregated?YesXCaseX 2D Linear24 Carton:XPalletX 2D Linear 2D Linear 2D Linear 2D LinearRegular Cost Vendor #: 2D LinearInvoice Cost (WAC) ($) $ Code #: Federal Excise Tax Per Unit of SaleFineline Code: As of date:*Please provide any additional Information on page new p. 3 for Designated Drop Ship :COST INFORMATIONWHOLESALER USE ONLY:Saleable UnitMVX Code:6838278501 Individual Unit NDC:*If Authorized Generic, other section fields are not applicablePRODUCT DESCRIPTION INFORMATIONP roduct Imprint: Product Color: Product Shape:Dosage Form:Strength:Size:(609) 730 1900 Fax:ROUNDLIGHT PINK TO PINK785 & SCORE Room between 20 and 25 C (68 77 pink to pink, mottled, capsule shaped, biconvex scored tablets debossed with 785 on one side and score line on another ROUTE 31 NORTHD irect-Ship OnlyADDITIONAL Product INFORMATIONZip:Box/Carton/Bundle/ Inner Pack:Item:1 BOTTLE OF 100 TABLETS# Pieces:Volume (Cube) LevelGTIN Product INFORMATIONC ompany Name: Address: YesIf Yes, was original Product purchased direct from mfr?)

4 What is the NDC selling unit?ITEM AND PACKING INFORMATION10/20/2017 ORDER INFORMATIONSPECIAL HANDLING AND STORAGE REQUIREMENTS*AB08534 DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATIONPHARMACY ORDER / BILL UNITN eitherCARDURA100 COUNTD imensions (US msmts.)DOXAZOSIN TABLETS USP, 4 MGIntroduction Type:ANDANew ItemApplication:NoAddress 2:156861945 Product INFORMATION208719 Description: Weight PHARMACEUTICALS (USA) :State:UPC:Pallet: (609) 730 19983840036382000002 FOR GENERIC DRUG copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF Product PACKAGING and Unit Dose, is item bar coded to unit dose for hospital scanning? Is this Product covered under the Trade Agreements Act (TAA)? Rec. sell unit to customer? Standard Pharmaceutical Product Information (Rx Product Only) August 2014 Final VersionDate:a.

5 Temperature Indicate the USP temperature range for this Number for NDA/ANDA/BLA (drug); PMA/510(k)(med device):Temperature RangeDUNS:Other Temperature Range RequirementProprietary Name (If Applicable) and Established Name: (write in)Selling Unit NDC:UPC:UDICVX Code:Is this Product to be shipped to customers on ice?NoIs this Product to be shipped to customers on dry ice? NoActive Ingredient(s):b. Contact for temperature excursion questions: Name:URL for Additional Product Information : Number:Group E-mail:City: NJKey Contact: c. Special regulations for Product in any states?NoPhone Number:Special returns requirements for this Product ? Product Therapeutic Classification:d. Store Product (unit of sale) upright?NoProtect Product (unit of sale) from light? NoIs the e. Shelf life: 24 Months a legend device?

6 NoInitial shelf life at launch (if different):Months reverse numbered?No co-licensed?NoIs the Is the Unit of SaleXBottleBox/Carton (Write-in, 1 Box of 10 Vials)AmpuleIf Unit Dose NDC, indicate NDC here: GlassMinimum order quantity?YesTubeCountry of OriginVial Liquid SglVial Liquid MultiIf Yes, how many of which package type? Vial Powder SqlEachVial Power MultiInner/Carton/PackOther: Write InX Case Authorized GenericI. Orange Book Rating:Rx billing unit to pharmacy:II. Generic Equivalent to What Brand?:X Each (Write-in, 1 Vial) Gram MilliliterDoes supplier meet DSCSA definition of manufacturer?GLN:Is Product exempt from DSCSA?If yes, select exemption:Other exemption - Write in: Depth Height WidthIs Product repackaged? Is Product sold by manufacturer's exclusive distributor?Has FDA granted waiver/exception/exemption for Product ?

7 If yes, attach documentation from GTIN-14 Serialized? NoXItemXX 2D Linear1If not, when? 1/1/2018 Box/Carton/Bundle/Inner Pack 2D LinearCase: Items aggregated?YesXCaseX 2D Linear12 Carton:XPalletX 2D Linear 2D Linear 2D Linear 2D LinearRegular Cost Vendor #: 2D LinearInvoice Cost (WAC) ($) $ Code #: Federal Excise Tax Per Unit of SaleFineline Code: As of date:*Please provide any additional Information on page new p. 3 for Designated Drop Ship :COST INFORMATIONWHOLESALER USE ONLY:Saleable UnitMVX Code:6838278510 Individual Unit NDC:*If Authorized Generic, other section fields are not applicablePRODUCT DESCRIPTION INFORMATIONP roduct Imprint: Product Color: Product Shape:Dosage Form:Strength:Size:(609) 730 1900 Fax:ROUNDLIGHT PINK TO PINK785 & SCORE Room between 20 and 25 C (68 77 pink to pink, mottled, capsule shaped, biconvex scored tablets debossed with 785 on one side and score line on another ROUTE 31 NORTHD irect-Ship OnlyADDITIONAL Product INFORMATIONZip:Box/Carton/Bundle/ Inner Pack:Item:1 BOTTLE OF 1000 TABLETS# Pieces:Volume (Cube) LevelGTIN Product INFORMATIONC ompany Name: Address: YesIf Yes, was original Product purchased direct from mfr?)

8 What is the NDC selling unit?ITEM AND PACKING INFORMATION10/20/2017 ORDER INFORMATIONSPECIAL HANDLING AND STORAGE REQUIREMENTS*AB08534 DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) INFORMATIONPHARMACY ORDER / BILL UNITN eitherCARDURA1000 COUNTD imensions (US msmts.)DOXAZOSIN TABLETS USP, 4 MGIntroduction Type:ANDANew ItemApplication:NoAddress 2:156861945 Product INFORMATION208719 Description: Weight PHARMACEUTICALS (USA) :State:UPC:Pallet: (609) 730 1998720036382000002 FOR GENERIC DRUG copy of SAFETY DATA SHEET (SDS) or non hazard letter, PACKAGE INSERT, LABEL AND PHOTO OF Product PACKAGING and Unit Dose, is item bar coded to unit dose for hospital scanning? Is this Product covered under the Trade Agreements Act (TAA)? 121/10 Rec. sell unit to customer?