Cetirizine Hydrochloride
- Product NDC
- 65162-003
- 11-digit product format
- 651620003
- Labeler code
- 65162
- Product ID
- 65162-003_f9d002fa-9c05-4275-a783-053bf1993ca0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA090765
- Marketing category
- ANDA
- Marketing start
- 2009-10-07
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- 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 | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-003-86 | Cetirizine Hydrochloride | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 11 |
| 65162-003-86 | Cetirizine Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-003 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241025_7d16ccca-6aa3-4575-9fa7-f57301801a81.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-003-86 | 65162000386 | 1 BOTTLE in 1 CARTON (65162-003-86) / 118 mL in 1 BOTTLE | 1 bottle | 2009-10-07 | 0000-00-00 | No | No | Current |