Viewing data from:

DIAZEPAM

ANDA

DIAZEPAM | A217468 | NAVINTA LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DIASTAT(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$208.12

per ea

Lowest NADAC/Unit

$173.31

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70710207902DIAZEPAM 10 MG RECTAL GEL (2PK)	$208.12	EA	Generic	—	2026-08-19
70710208002DIAZEPAM 20 MG RECTAL GEL (2PK)	$173.31	EA	Generic	—	2026-08-19

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

API Supply Chain5 active DMFs4 inactive

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

CAMBREX PROFARMACO MILANO SRLDIAZEPAM

DMF 14781970

FIS FABBRICA ITALIANA SINTETICI SPADIAZEPAM

DMF 31641978

CENTAUR PHARMACEUTICALS PRIVATE LTDDIAZEPAM USP

DMF 218602008

R L FINE CHEM PVT LTDDIAZEPAM

DMF 338582019

NAVINTA LLCDIAZEPAM USP

DMF 388442023

DELMAR CHEMICALS INCInactiveDIAZEPAM USP BULK

DMF 25821976

POLFA TARCHOMINInactiveDIAZEPAM, BULK

DMF 35231979

GEDEON RICHTER LTDInactiveDIAZEPAM USP

DMF 60711985

FDC PRIVATE LTDInactiveDIAZEPAM U.S.P. XXI

DMF 70251987

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 13, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG/0.5ML (5MG/ML)

0 patents0 exclusivities▴

GEL;RECTAL | Approved: Nov 14, 2025

No patent or exclusivity listings for this strength.

#002 — 10MG/2ML (5MG/ML)

0 patents0 exclusivities▾

GEL;RECTAL | Approved: Nov 14, 2025

#003 — 20MG/4ML (5MG/ML)

0 patents0 exclusivities▾

GEL;RECTAL | Approved: Nov 14, 2025