Cetirizine Hydrochloride

Product NDC
71205-435
11-digit product format
712050435
Labeler code
71205
Product ID
71205-435_faa9abcb-37ba-4e5c-8404-4e13b531febd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076601
Marketing category
ANDA
Marketing start
2014-05-01
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
64O047KTOACETIRIZINE HYDROCHLORIDE83881-52-1CETIRIZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-435-04712050435041 BOTTLE in 1 CARTON (71205-435-04) / 120 mL in 1 BOTTLE1 bottle2020-03-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cetirizine Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL)Proficient Rx LP2024-07-01HUMAN PRESCRIPTION DRUG LABEL2