Hydrocodone Bitartrate

These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE CAPSULES . HYDROCODONE BITARTRATE extended-release capsules, for oral use, CII Initial U.S. Approval: 1943

Approved

Approval ID

a7b8ea07-e926-f0a5-c20d-92f23ed350d0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2023

Manufacturers

FDA

Alvogen Inc.

DUNS: 008057330

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrocodone Bitartrate

PRODUCT DETAILS

NDC Product Code47781-413

Application NumberANDA206986

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 27, 2016

Generic NameHydrocodone Bitartrate

INGREDIENTS (18)

Hydrocodone BitartrateActive

Quantity: 40 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

TalcInactive

Code: 7SEV7J4R1U

Classification: IACT

Ammonio Methacrylate Copolymer Type BInactive

Code: 161H3B14U2

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

SucroseInactive

Code: C151H8M554

Classification: IACT

FD&C Blue No. 1Inactive

Code: H3R47K3TBD

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

Fd&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Hydrocodone Bitartrate

PRODUCT DETAILS

NDC Product Code47781-409

Application NumberANDA206986

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 27, 2016

Generic NameHydrocodone Bitartrate

INGREDIENTS (18)

Hydrocodone BitartrateActive

Quantity: 10 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

Ammonio Methacrylate Copolymer Type BInactive

Code: 161H3B14U2

Classification: IACT

SucroseInactive

Code: C151H8M554

Classification: IACT

TalcInactive

Code: 7SEV7J4R1U

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C Blue No. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

Fd&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Hydrocodone Bitartrate

PRODUCT DETAILS

NDC Product Code47781-410

Application NumberANDA206986

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 27, 2016

Generic NameHydrocodone Bitartrate

INGREDIENTS (19)

SucroseInactive

Code: C151H8M554

Classification: IACT

Hydrocodone BitartrateActive

Quantity: 15 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

TalcInactive

Code: 7SEV7J4R1U

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Ammonio Methacrylate Copolymer Type BInactive

Code: 161H3B14U2

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C Blue No. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

Fd&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

Fd&C Red No. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

Hydrocodone Bitartrate

PRODUCT DETAILS

NDC Product Code47781-411

Application NumberANDA206986

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 27, 2016

Generic NameHydrocodone Bitartrate

INGREDIENTS (18)

Hydrocodone BitartrateActive

Quantity: 20 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

SucroseInactive

Code: C151H8M554

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C Blue No. 1Inactive

Code: H3R47K3TBD

Classification: IACT

Ammonio Methacrylate Copolymer Type BInactive

Code: 161H3B14U2

Classification: IACT

TalcInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

Fd&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

Hydrocodone Bitartrate

PRODUCT DETAILS

NDC Product Code47781-414

Application NumberANDA206986

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 27, 2016

Generic NameHydrocodone Bitartrate

INGREDIENTS (18)

Ammonio Methacrylate Copolymer Type BInactive

Code: 161H3B14U2

Classification: IACT

Hydrocodone BitartrateActive

Quantity: 50 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

SucroseInactive

Code: C151H8M554

Classification: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C Blue No. 1Inactive

Code: H3R47K3TBD

Classification: IACT

TalcInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

Fd&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Hydrocodone Bitartrate

PRODUCT DETAILS

NDC Product Code47781-412

Application NumberANDA206986

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 27, 2016

Generic NameHydrocodone Bitartrate

INGREDIENTS (19)

Hydrocodone BitartrateActive

Quantity: 30 mg in 1 1

Code: NO70W886KK

Classification: ACTIB

Silicon DioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

TalcInactive

Code: 7SEV7J4R1U

Classification: IACT

SucroseInactive

Code: C151H8M554

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Ammonio Methacrylate Copolymer Type BInactive

Code: 161H3B14U2

Classification: IACT

FD&C Blue No. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8B

Classification: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357

Classification: IACT

Fd&C Red No. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3

Classification: IACT

Fd&C Blue No. 2Inactive

Code: L06K8R7DQK

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Sodium Lauryl SulfateInactive

Code: 368GB5141J

Classification: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

AI-Powered Research

Premium Access

Hydrocodone Bitartrate

Products 6

Hydrocodone Bitartrate

PRODUCT DETAILS

INGREDIENTS (18)

Hydrocodone Bitartrate

PRODUCT DETAILS

INGREDIENTS (18)

Hydrocodone Bitartrate

PRODUCT DETAILS

INGREDIENTS (19)

Hydrocodone Bitartrate

PRODUCT DETAILS

INGREDIENTS (18)

Hydrocodone Bitartrate

PRODUCT DETAILS

INGREDIENTS (18)

Hydrocodone Bitartrate

PRODUCT DETAILS

INGREDIENTS (19)

MedPath

Product

Company

Legal