Childrens Cetirizine Hydrochloride
- Product NDC
- 51672-2147
- 11-digit product format
- 516722147
- Labeler code
- 51672
- Product ID
- 51672-2147_390d2d99-47af-c154-e063-6294a90ac905
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090182
- Marketing category
- ANDA
- Marketing start
- 2025-03-20
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Cetirizine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-2147-1 | Childrens Cetirizine Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 51672-2147-1 | Childrens Cetirizine Hydrochloride | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 2 |
| 51672-2147-8 | Childrens Cetirizine Hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 2 |
| 51672-2147-8 | Childrens Cetirizine Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-2147 | CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 1 | Current NDC, 4 package rows | 20250323_30cbaa91-2216-efd2-e063-6294a90aaaed.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51672-2147-1 | 51672214701 | 1 BOTTLE in 1 CARTON (51672-2147-1) / 240 mL in 1 BOTTLE | 1 bottle | 2025-03-20 | No | No | Current |
| 51672-2147-8 | 51672214708 | 1 BOTTLE in 1 CARTON (51672-2147-8) / 120 mL in 1 BOTTLE | 1 bottle | 2025-03-20 | No | No | Current |