Cetirizine Hydrochloride
- Product NDC
- 68071-2571
- 11-digit product format
- 680712571
- Labeler code
- 68071
- Product ID
- 68071-2571_fd90ffc6-a1de-e02e-e053-6294a90a4e7c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077498
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- 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 |
|---|
| 68071-2571-7 | 68071257107 | 7 TABLET in 1 BOTTLE (68071-2571-7) | 7 tablet | 2021-11-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Cetirizine Hydrochloride | NuCare Pharmaceuticals,Inc. | 2024-08-12 | HUMAN OTC DRUG LABEL | 2 |