Cetirizine Hydrochloride
- Product NDC
- 65162-046
- 11-digit product format
- 651620046
- Labeler code
- 65162
- Product ID
- 65162-046_b1326566-e6ae-44c3-a1c5-3b0f5be3fc1f
- 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
- 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 Hydrochloride
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-046-03 | Cetirizine Hydrochloride | 1 in 1 CARTON | TABLET | 1 | | 7 |
| 65162-046-03 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 65162-046-50 | Cetirizine Hydrochloride | 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 |
|---|
| 65162-046 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) TABLET [AMNEAL PHARMACEUTICALS LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240808_273172b2-9aaf-46fb-a1ce-2961650eacd3.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 |
|---|
| 65162-046-03 | 65162004603 | 1 BOTTLE in 1 CARTON (65162-046-03) / 30 TABLET in 1 BOTTLE | 1 bottle | 2010-01-21 | No | No | Historical |
| 65162-046-50 | 65162004650 | 500 TABLET in 1 BOTTLE (65162-046-50) | 500 tablet | 2010-01-21 | No | No | Historical |