Viewing data from:

CETIRIZINE HYDROCHLORIDE ALLERGY

ANDA

CETIRIZINE HYDROCHLORIDE | A078427 | GLENMARK PHARMACEUTICALS INC USA

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs

Highest NADAC/Unit

$0.0640

per ea

Lowest NADAC/Unit

$0.0640

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70677127901FT AD ALLERGY (CETRZN) 10 MG TB	$0.0640	EA	Generic	—	2026-06-17
70677127902FT AD ALLERGY (CETRZN) 10 MG TB	$0.0640	EA	Generic	—	2026-06-17
70677127903FT AD ALLERGY (CETRZN) 10 MG TB	$0.0640	EA	Generic	—	2026-06-17
70677127904FT AD ALLERGY (CETRZN) 10 MG TB	$0.0640	EA	Generic	—	2026-06-17
70677127905FT AD ALLERGY (CETRZN) 10 MG TB	$0.0640	EA	Generic	—	2026-06-17

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

API Supply Chain12 active DMFs3 inactive

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

UCB PHARMA SACETIRIZINE HYDROCHLORIDE

DMF 68531987

UCB FARCHIM SACETIRIZINE HYDROCHLORIDE

DMF 175132004

MATRIX PHARMACORP PRIVATE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 177412004

SOLARA ACTIVE PHARMA SCIENCES LTDCETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE USP

DMF 205392007

CALYX CHEMICALS AND PHARMACEUTICALS LTDCETIRIZINE HYDROCHLORIDE

DMF 213962008

CIMA LABORATORIES INCCETIRIZINE HYDROCHLORIDE COATED GRANULES

DMF 226802009

IPCA LABORATORIES LTDCETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS)

DMF 260332012

UNICHEM LABORATORIES LTDCETIRIZINE HYDROCHLORIDE USP

DMF 280592014

THINQ PHARMA-CRO LTDCETIRIZINE HYDROCHLORIDE USP

DMF 288872015

GRANULES INDIA LTDCETIRIZINE HYDROCHLORIDE, USP

DMF 300632016

SUPRIYA LIFESCIENCE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 391992024

PRAVEEN LABORATORIES PRIVATE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 435172026

IPCA LABORATORIES LTDInactiveCETIRIZINE HYDROCHLORIDE USP

DMF 209972007

IWAKI SEIYAKU CO LTDInactiveCETIRIZINE HYDROCHLORIDE

DMF 218642008

DISHMAN CARBOGEN AMCIS LTDInactiveCETIRIZINE HYDROCHLORIDE

DMF 261792012

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 9, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#003 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 28, 2007

No patent or exclusivity listings for this strength.

#004 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 28, 2007