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MORPHINE SULFATE

ANDA

MORPHINE SULFATE | A212451 | ALKEM LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MORPHINE SULFATE(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.4148

per ea

Lowest NADAC/Unit

$0.2354

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
67877067101MORPHINE SULFATE IR 30 MG TAB	$0.4148	EA	Generic	—	2026-06-17
67877067001MORPHINE SULFATE IR 15 MG TAB	$0.2354	EA	Generic	—	2026-06-17

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

API Supply Chain4 active DMFs6 inactive

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

SPECGX LLCMORPHINE SULFATE

DMF 58571985

NORAMCO LLCMORPHINE SULFATE

DMF 69671987

VERANOVA LPMORPHINE SULFATE USP

DMF 215882008

NORAMCO LLCMORPHINE SULFATE, USP

DMF 293172015

PENICK CORPInactiveMORPHINE SULFATE

DMF 66801986

MACFARLAN SMITH LTDInactiveMORPHINE SULFATE

DMF 83281989

MALLINCKRODT INCInactiveMORPHINE SULFATE INJECTION USP

DMF 115291995

ELAN PHARMA LTDInactiveMORPHINE SULFATE

DMF 128081997

SIEGFRIED USA LLCInactiveMORPHINE SULFATE USP

DMF 196932006

CODY LABORATORIES INCInactiveMORPHINE SULFATE, USP

DMF 280402014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 7, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 3, 2020

No patent or exclusivity listings for this strength.

#002 — 30MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 3, 2020