Cetirizine Hydrochloride
- Product NDC
- 71335-9612
- 11-digit product format
- 713359612
- Labeler code
- 71335
- Product ID
- 71335-9612_feff9aa9-70f0-4e25-a822-f219cd1dde9a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2018-12-17
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- 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 UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 64O047KTOA | CETIRIZINE HYDROCHLORIDE | 83881-52-1 | CETIRIZINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-9612-1 | 71335961201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9612-1) | 2023-01-03 | No | No | Historical |
| 71335-9612-2 | 71335961202 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-9612-2) | 2023-01-03 | No | No | Historical |
| 71335-9612-3 | 71335961203 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-9612-3) | 2023-01-03 | No | No | Historical |
| 71335-9612-4 | 71335961204 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-9612-4) | 2023-01-03 | No | No | Historical |
| 71335-9612-5 | 71335961205 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-9612-5) | 2023-01-03 | No | No | Historical |
| 71335-9612-6 | 71335961206 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9612-6) | 2023-01-03 | No | No | Historical |
| 71335-9612-7 | 71335961207 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-9612-7) | 2023-01-03 | No | No | Historical |
| 71335-9612-8 | 71335961208 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9612-8) | 2023-01-03 | No | No | Historical |
| 71335-9612-9 | 71335961209 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9612-9) | 2023-01-03 | No | No | Historical |