Cetirizine Hydrochloride
- Product NDC
- 70518-3468
- 11-digit product format
- 705183468
- Labeler code
- 70518
- Product ID
- 70518-3468_f2155330-ce5e-1c75-e053-2995a90aad52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2022-08-09
- Marketing end
- 0000-00-00
- 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3468-0 | 70518346800 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3468-0) | 2022-08-09 | 0000-00-00 | No | No | Current |
| 70518-3468-1 | 70518346801 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3468-1) | 2022-08-10 | 0000-00-00 | No | No | Current |
| 70518-3468-2 | 70518346802 | 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3468-2) | 2022-12-06 | 0000-00-00 | No | No | Current |