Cetirizine Hydrochloride
- Product NDC
- 65162-684
- 11-digit product format
- 651620684
- Labeler code
- 65162
- Product ID
- 65162-684_9cc0ee28-2f21-4c0a-90fe-b22b3fe321c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cetirizine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA090766
- 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 |
|---|
| 65162-684-86 | Cetirizine Hydrochloride | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 18 |
| 65162-684-90 | Cetirizine Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 18 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-684 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE) SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20241025_365cbabe-535b-4c34-852b-6cd63782e3e5.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 |
|---|
| 65162-684-86 | 65162068486 | 118 mL in 1 BOTTLE (65162-684-86) | 118 ml | 2009-10-07 | 0000-00-00 | No | No | Current |
| 65162-684-90 | 65162068490 | 473 mL in 1 BOTTLE (65162-684-90) | 473 ml | 2009-10-07 | 0000-00-00 | No | No | Current |