Cetirizine Hydrochloride
- Product NDC
- 76162-009
- 11-digit product format
- 761620009
- Labeler code
- 76162
- Product ID
- 76162-009_7baa79c5-be46-4b09-8cae-c306edb7f97a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- TOPCO ASSOCIATES LLC
- Application
- ANDA213557
- Marketing category
- ANDA
- Marketing start
- 2024-06-06
- 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 |
|---|
| 76162-009-76 | 76162000976 | 4 BLISTER PACK in 1 CARTON (76162-009-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 blister pack | 2024-06-06 | No | No | Historical |