FDA.report

Cetirizine Hydrochloride

Product NDC
43598-811
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA078343
Marketing category
ANDA
Substance
CETIRIZINE HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
43598-811-051 BOTTLE in 1 CARTON (43598-811-05) / 500 TABLET, FILM COATED in 1 BOTTLE2018-12-17NoHistorical
43598-811-12100 TABLET, FILM COATED in 1 BOTTLE (43598-811-12) 2019-09-03NoHistorical
43598-811-13300 TABLET, FILM COATED in 1 BOTTLE (43598-811-13) 2019-09-03NoHistorical
43598-811-15500 TABLET, FILM COATED in 1 BOTTLE (43598-811-15) 2019-09-03NoHistorical
43598-811-301 BOTTLE in 1 CARTON (43598-811-30) / 300 TABLET, FILM COATED in 1 BOTTLE2018-12-17NoHistorical
43598-811-901 BOTTLE in 1 CARTON (43598-811-90) / 90 TABLET, FILM COATED in 1 BOTTLE2018-12-17NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cetirizine Hydrochloride TabletsPreferred Pharmaceuticals Inc.2026-03-25HUMAN OTC DRUG LABEL4
Cetirizine Hydrochloride TabletsProficient Rx LP2026-03-01HUMAN OTC DRUG LABEL4
Cetirizine Hydrochloride TabletsSportpharm LLC2026-02-06HUMAN OTC DRUG LABEL2
Cetirizine Hydrochloride TabletsNorthwind Health Company, LLC2026-01-01HUMAN OTC DRUG LABEL5
Cetirizine Hydrochloride TabletsVERITYRX, LLC2025-10-31HUMAN OTC DRUG LABEL1
Cetirizine Hydrochloride TabletsBryant Ranch Prepack2025-10-28HUMAN OTC DRUG LABEL102
Cetirizine Hydrochloride TabletsDr. Reddy's Laboratories Inc.2025-07-17HUMAN OTC DRUG LABEL2
Cetirizine Hydrochloride TabletsDr. Reddy's Laboratories Inc.2025-07-16HUMAN OTC DRUG LABEL6
Cetirizine Hydrochloride TabletsBryant Ranch Prepack2024-07-25HUMAN OTC DRUG LABEL101
Cetirizine Hydrochloride TabletsNuCare Pharmaceuticals,Inc.2023-07-17HUMAN OTC DRUG LABEL3