Cetirizine Hydrochloride
- Product NDC
- 53329-652
- 11-digit product format
- 533290652
- Labeler code
- 53329
- Product ID
- 53329-652_efd12ec8-8f3d-c1e3-e053-2995a90a685a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medline Industries, LP
- Application
- ANDA077498
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- 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 [MEDLINE INDUSTRIES, INC.] | 1 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53329-652 | CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, LP] | 7 | Legacy NDC | 20221217_6823d475-84c6-4d9f-838d-925ccfb96c97.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53329-652-38 | 53329065238 | 90 TABLET in 1 BOTTLE (53329-652-38) | 90 tablet | 2007-12-27 | 0000-00-00 | No | No | Current |