Cetirizine Hydrochloride
- Product NDC
- 68788-0790
- 11-digit product format
- 687880790
- Labeler code
- 68788
- Product ID
- 68788-0790_02e0a08a-5b47-4173-8c97-6fa03ded7912
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA077829
- Marketing category
- ANDA
- Marketing start
- 2009-10-01
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cetirizine Hydrochloride | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-0790 | CETIRIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 14 | Legacy NDC | 20250227_3fc53b32-704b-4586-aa8c-26a2a71a155a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-0790-0 | 68788079000 | 100 TABLET in 1 BOTTLE (68788-0790-0) | 100 tablet | 2009-10-01 | 0000-00-00 | No | No | Current |
| 68788-0790-1 | 68788079001 | 14 TABLET in 1 BOTTLE (68788-0790-1) | 14 tablet | 2009-10-01 | 0000-00-00 | No | No | Current |
| 68788-0790-3 | 68788079003 | 30 TABLET in 1 BOTTLE (68788-0790-3) | 30 tablet | 2009-10-01 | 0000-00-00 | No | No | Current |
| 68788-0790-5 | 68788079005 | 15 TABLET in 1 BOTTLE (68788-0790-5) | 15 tablet | 2009-10-01 | 0000-00-00 | No | No | Current |
| 68788-0790-6 | 68788079006 | 60 TABLET in 1 BOTTLE (68788-0790-6) | 60 tablet | 2009-10-01 | 0000-00-00 | No | No | Current |
| 68788-0790-9 | 68788079009 | 90 TABLET in 1 BOTTLE (68788-0790-9) | 90 tablet | 2009-10-01 | 0000-00-00 | No | No | Current |