Viewing data from:

CETIRIZINE HYDROCHLORIDE

ANDA

CETIRIZINE HYDROCHLORIDE | A078488 | BIONPHARMA INC

1 strength0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.1438

per ml

Lowest NADAC/Unit

$0.0218

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69452042688CETIRIZINE HCL 1 MG/ML SOLN	$0.1438	ML	Generic	—	2026-06-17
69452042655CETIRIZINE HCL 1 MG/ML SOLN	$0.0218	ML	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.

Products (1)

#001 — 5MG/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Oct 6, 2008

No patent or exclusivity listings for this strength.