Viewing data from:

CETIRIZINE HYDROCHLORIDE ALLERGY

ANDA

CETIRIZINE HYDROCHLORIDE | A077498 | SUN PHARMACEUTICAL INDUSTRIES LTD

4 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
51660093901CETIRIZINE HCL 10 MG TABLET	$0.0640	EA	Generic	—	2026-06-17
51660093930CETIRIZINE HCL 10 MG TABLET	$0.0640	EA	Generic	—	2026-06-17
51660093953ALLERGY RLF (CETRZN) 10 MG TAB	$0.0640	EA	Generic	—	2026-06-17
51660093954CETIRIZINE HCL 10 MG TABLET	$0.0640	EA	Generic	—	2026-06-17
51660093990CETIRIZINE HCL 10 MG TABLET	$0.0640	EA	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 | 3 NDCs (3 FSS)

Lowest Price

$2.89

Highest Price

$11.44

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
10135-0762-01CETIRIZINE HCL 10MG TAB	$3.21	FSS	Marlex Pharmaceuticals, Inc.	01/31/2030
10135-0762-05CETIRIZINE HCL 10MG TAB	$11.44	FSS	Marlex Pharmaceuticals, Inc.	01/31/2030
10135-0762-90CETIRIZINE HCL 10MG TAB	$2.89	FSS	Marlex Pharmaceuticals, Inc.	01/31/2030

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

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 (4)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 27, 2007

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 27, 2007

#003 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 27, 2007

#004 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 27, 2007