Cetirizine Hydrochloride
- Product NDC
- 65162-145
- 11-digit product format
- 651620145
- Labeler code
- 65162
- Product ID
- 65162-145_2231625e-ba4f-4106-81ed-12137d0464a6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA078780
- Marketing category
- ANDA
- Marketing start
- 2010-01-21
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 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 Hydrochloride
- Brand name suffix
- Hives Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014676 |
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 |
|---|
| 65162-145-03 | Cetirizine HydrochlorideHives Relief | 1 in 1 CARTON | TABLET | 1 | | 7 |
| 65162-145-03 | Cetirizine HydrochlorideHives Relief | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 65162-145-50 | Cetirizine HydrochlorideHives Relief | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-145 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241025_aad39214-5bf1-427b-a00e-410224c51c95.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 |
|---|
| 65162-145-03 | 65162014503 | 1 BOTTLE in 1 CARTON (65162-145-03) / 30 TABLET in 1 BOTTLE | 1 bottle | 2010-01-21 | No | No | Historical |
| 65162-145-50 | 65162014550 | 500 TABLET in 1 BOTTLE (65162-145-50) | 500 tablet | 2010-01-21 | No | No | Historical |