Viewing data from:

HYDROCODONE BITARTRATE

ANDA

HYDROCODONE BITARTRATE | A206986 | ALVOGEN INC

6 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Recro Gainesville LLC v. Alvogen Malta Operations Ltd. 1:2014cv01364 2 patentsANDA 206986hydrocodone bitartrate	D. Del.	2014-11-03	Terminated 2016-09-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$7.97

per ea

Lowest NADAC/Unit

$7.97

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
47781041060HYDROCODONE ER 15 MG CAPSULE	$7.97	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain7 active DMFs8 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED USA LLCHYDROCODONE BITARTRATE USP

DMF 194602006

VERANOVA LPHYDROCODONE BITARTRATE USP

DMF 198482006

NORAMCO LLCHYDROCODONE BITARTRATE DRUG SUBSTANCE

DMF 211582007

NORAMCO LLCHYDROCODONE BITARTRATE, USP

DMF 236812010

CHATTEM CHEMICALS INCHYDROCODONE BITARTRATE USP

DMF 252852015

SPECGX LLCHYDROCODONE BITARTRATE USP CRYSTALS (NP)

DMF 259612013

CAMBREX CHARLES CITY INCHYDROCODONE BITARTRATE HEMIPENTAHYDRATE

DMF 293712015

SPECGX LLCInactiveHYDROCODONE BITARTRATE USP CRYSTALS

DMF 48841983

PENCO OF LYNDHURST INCInactiveHYDROCODONE BITARTRATE POWDER

DMF 58911985

NORAMCO INCInactiveHYDROCODONE BITARTRATE

DMF 70781987

WATSON LABORATORIES INCInactiveHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG\650 MG

DMF 120251996

WATSON LABORATORIES INCInactiveHYDROCODONE BITARTRATE TABLETS, 10 MG

DMF 120291996

JOHNSON MATTHEY PHARMACEUTICAL MATERIALSInactiveHYDROCODONE BITARTRATE, USP

DMF 128481998

CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INCInactiveHYDROCODONE BITARTRATE, USP

DMF 280412014

CODY LABORATORIES INCInactiveHYDROCODONE BITARTRATE, USP

DMF 321012018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 18, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.