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HYDROMORPHONE HYDROCHLORIDE

ANDA

HYDROMORPHONE HYDROCHLORIDE | A205814 | AUROLIFE PHARMA LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DILAUDID(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 3 NDCs

Highest NADAC/Unit

$0.5490

per ea

Lowest NADAC/Unit

$0.1708

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
13107010901HYDROMORPHONE 8 MG TABLET	$0.5490	EA	Generic	—	2026-10-21
13107010801HYDROMORPHONE 4 MG TABLET	$0.2202	EA	Generic	—	2026-10-21
13107010701HYDROMORPHONE 2 MG TABLET	$0.1708	EA	Generic	—	2026-10-21

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

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$4.41

Highest Price

$12.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
13107-0107-01HYDROMORPHONE HCL 2MG TAB	$4.41	FSS	Aurobindo Pharma USA Inc.	03/14/2027
13107-0108-01HYDROMORPHONE HCL 4MG TAB	$6.02	FSS	Aurobindo Pharma USA Inc.	03/14/2027
13107-0109-01HYDROMORPHONE HCL 8MG TAB	$12.85	FSS	Aurobindo Pharma USA Inc.	03/14/2027

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.

Products (3)

Sort:

#001 — 2MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 13, 2016

No patent or exclusivity listings for this strength.

#002 — 4MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 13, 2016

#003 — 8MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 13, 2016