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TEMAZEPAM

ANDA

TEMAZEPAM | A203482 | AMNEAL PHARMACEUTICALS

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: RESTORIL(TE code: AB)

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.0922

per ea

Lowest NADAC/Unit

$0.0786

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
53746055701TEMAZEPAM 30 MG CAPSULE	$0.0922	EA	Generic	—	2026-06-17
53746055601TEMAZEPAM 15 MG CAPSULE	$0.0786	EA	Generic	—	2026-06-17

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

API Supply Chain4 active DMFs4 inactive

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

CAMBREX PROFARMACO MILANO SRLTEMAZEPAM

DMF 43761981

FIS FABBRICA ITALIANA SINTETICI SPATEMAZEPAM

DMF 52231983

MATRIX PHARMACORP PRIVATE LTDTEMAZEPAM USP

DMF 231602009

R L FINE CHEM PVT LTDTEMAZEPAM

DMF 389982023

WYETH INCInactiveTEMAZEPAM

DMF 31931978

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveTEMAZEPAM

DMF 55071984

WYETH-AYERST LABORATORIESInactiveTEMAZEPAM

DMF 61621986

CENTAUR PHARMACEUTICALS PVT LTDInactiveTEMAZEPAM USP

DMF 253642011

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

Products (4)

Sort:

#001 — 7.5MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 23, 2016

No patent or exclusivity listings for this strength.

#002 — 15MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 23, 2016

#003 — 22.5MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 23, 2016

#004 — 30MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 23, 2016