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DIPHENHYDRAMINE HYDROCHLORIDE

ANDA

DIPHENHYDRAMINE HYDROCHLORIDE | A040466 | APP PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.9399

per ml

Lowest NADAC/Unit

$0.9399

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
63323066416DIPHENHYDRAMINE 50 MG/ML VIAL	$0.9399	ML	Generic	—	2026-06-17
63323066401DIPHENHYDRAMINE 50 MG/ML VIAL	$0.9399	ML	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$23.37

Highest Price

$23.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63323-0664-01DIPHENHYDRAMINE HCL 50MG/ML INJ SDV	$23.37	FSS	Fresenius Kabi, LLC	05/14/2030

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

API Supply Chain6 active DMFs6 inactive

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

BEIJING TAIYANG PHARMACEUTICAL INDUSTRY CO LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 197372006

WANBURY LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 205722007

SUPRIYA LIFESCIENCE LTDDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 351742020

GLAND PHARMA LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 359532021

S. S. PHARMACHEMDIPHENHYDRAMINE

DMF 421072025

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 437752026

GANES CHEMICALS INC PENNSVILLE DIVInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 12371968

FOURTH PHARMACEUTICAL WORKSInactiveDIPHENHYDRAMINE, BULK FORM (SYNTHESIS)

DMF 40741981

UNICHEM LABORATORIES LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 56531984

UNICHEM LABORATORIES LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 76611988

KAMUD DRUGS PVT LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 226012009

SOUVIN PHARMACEUTICAL I PVT LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 267722012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 28, 2002

No patent or exclusivity listings for this strength.