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HYDROMORPHONE HYDROCHLORIDE

ANDA

HYDROMORPHONE HYDROCHLORIDE | A205629 | OSMOTICA PHARMACEUTICAL US LLC

5 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 3 NDCs

Highest NADAC/Unit

$11.82

per ea

Lowest NADAC/Unit

$5.83

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
13811070310HYDROMORPHONE HCL ER 16 MG TAB	$11.82	EA	Generic	—	2026-08-19
13811070210HYDROMORPHONE HCL ER 12 MG TAB	$10.26	EA	Generic	—	2026-08-19
13811070110HYDROMORPHONE HCL ER 8 MG TAB	$5.83	EA	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$731.36

Highest Price

$1927.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
13811-0701-10HYDROMORPHONE HCL 8MG 24HR TAB,SA	$731.36	FSS	Golden State Medical Supply, Inc.	06/14/2028
13811-0702-10HYDROMORPHONE HCL 12MG 24HR TAB,SA	$1093.08	FSS	Golden State Medical Supply, Inc.	06/14/2028
13811-0703-10HYDROMORPHONE HCL 16MG 24HR TAB,SA	$1457.44	FSS	Golden State Medical Supply, Inc.	06/14/2028
13811-0704-10HYDROMORPHONE HCL 32MG 24HR TAB,SA	$1927.55	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain4 active DMFs6 inactive

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

NORAMCO LLCHYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 195612006

SIEGFRIED USA LLCHYDROMORPHONE HYDROCHLORIDE USP

DMF 220822008

SPECGX LLCHYDROMORPHONE HYDROCHLORIDE USP (NP)

DMF 257662012

CHATTEM CHEMICALS INCHYDROMORPHONE HYDROCHLORIDE, USP

DMF 309952016

DIOSYNTH BVInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 70111987

TAKEDA PHARMACEUTICAL CO LTDInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 70711987

SPECGX LLCInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 72371987

NORAMCO LLCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 163512002

CODY LABORATORIES INCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 288042014

NORAMCO LLCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 319942020

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 11, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 8MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 7, 2016

No patent or exclusivity listings for this strength.

#002 — 12MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 7, 2016

#003 — 16MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 7, 2016

#004 — 32MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 7, 2016

#005 — 24MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 30, 2024