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AZELASTINE HYDROCHLORIDE

ANDA

AZELASTINE HYDROCHLORIDE | A204660 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.2787

per ml

Lowest NADAC/Unit

$0.2787

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
65162067684AZELASTINE 0.1% (137 MCG) SPRY	$0.2787	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 | 2 NDCs (2 FSS)

Lowest Price

$8.25

Highest Price

$9.69

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42291-0094-30AZELASTINE HCL 137MCG/SPRAY INHL,NASAL,30ML	$8.25	FSS	AvKare, LLC	06/14/2028
65162-0676-84AZELASTINE HCL 137MCG/SPRAY INHL,NASAL,30ML	$9.69	FSS	AvKare, LLC	06/14/2028

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

API Supply Chain9 active DMFs2 inactive

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

EVONIK OPERATIONS GMBHAZELASTINE HYDROCHLORIDE

DMF 154402001

DAITO PHARMACEUTICAL CO LTDAZELASTINE HYDROCHLORIDE DAITO USP

DMF 183982005

CURIA ITALY SRLAZELASTINE HYDROCHLORIDE

DMF 194222006

ESTEVE QUIMICA SAAZELASTINE HYDROCHLORIDE

DMF 224272009

ZYDUS LIFESCIENCES LTDAZELASTINE HYDROCHLORIDE

DMF 229192009

KOREA UNITED PHARMACEUTICALS INCAZELASTINE HYDROCHLORIDE

DMF 243172010

MSN LABORATORIES PRIVATE LTDAZELASTINE HYDROCHLORIDE USP [ROUTE CODE - "AH"]

DMF 253562011

CORAL DRUGS PRIVATE LTDAZELASTINE HYDROCHLORIDE USP

DMF 362052021

ZHEJIANG LEPU PHARMACEUTICAL CO LTDAZELASTINE HYDROCHLORIDE, USP

DMF 367482022

CIPLA LTDInactiveAZELASTINE HYDROCHLORIDE BP/PH.EUR

DMF 201862008

JIANGSU HENGRUI MEDICINE CO LTDInactiveAZELASTINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 256262011

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

Products (1)

#001 — 0.137MG/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Aug 28, 2017

No patent or exclusivity listings for this strength.