Cetirizine Hydrochloride
- Product NDC
- 71610-821
- 11-digit product format
- 716100821
- Labeler code
- 71610
- Product ID
- 71610-821_15eab1a2-2c02-7134-e063-6394a90af5af
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077498
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- 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 |
|---|
| 71610-821-30 | 71610082130 | 30 TABLET in 1 BOTTLE (71610-821-30) | 30 tablet | 2024-04-12 | No | No | Historical |
| 71610-821-60 | 71610082160 | 90 TABLET in 1 BOTTLE (71610-821-60) | 90 tablet | 2024-04-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Cetirizine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | 2024-04-12 | HUMAN OTC DRUG LABEL | 1 |