Cetirizine
- Product NDC
- 50090-7594
- 11-digit product format
- 500907594
- Labeler code
- 50090
- Product ID
- 50090-7594_d4b37212-07e4-468e-9420-738ead7b77ad
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078336
- Marketing category
- ANDA
- Marketing start
- 2018-06-29
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7594-0 | 50090759400 | 1 BOTTLE in 1 CARTON (50090-7594-0) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-07-03 | No | No | Historical |
| 50090-7594-1 | 50090759401 | 1 BOTTLE in 1 CARTON (50090-7594-1) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-07-03 | No | No | Historical |