Cetirizine HCl
- Product NDC
- 57896-992
- 11-digit product format
- 578960992
- Labeler code
- 57896
- Product ID
- 57896-992_3389e955-a045-abfd-e063-6394a90a4e02
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- GERI-CARE PHARMACEUTICAL CORP
- Application
- ANDA076047
- Marketing category
- ANDA
- Marketing start
- 2025-04-24
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57896-992-01 | Cetirizine HCl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57896-992 | CETIRIZINE HCL (CETIRIZINE) TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP] | 1 | Current NDC, 1 package rows | 20250426_3389e947-b7d1-6caf-e063-6294a90a2238.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 57896-992-01 | 57896099201 | 100 TABLET, FILM COATED in 1 BOTTLE (57896-992-01) | 2025-04-24 | No | No | Current |