CETIRIZINE HYDROCHLORIDE
- Product NDC
- 57237-358
- 11-digit product format
- 572370358
- Labeler code
- 57237
- Product ID
- 57237-358_836319e1-8b7b-46a4-8303-5d241c6dcb98
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA091327
- Marketing category
- ANDA
- Marketing start
- 2025-11-11
- 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
- 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 | 1 mg/mL |
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 |
|---|
| 57237-358-12 | CETIRIZINE HYDROCHLORIDE | 120 mL in 1 BOTTLE, PLASTIC | SOLUTION | 120 | | 1 |
| 57237-358-24 | CETIRIZINE HYDROCHLORIDE | 240 mL in 1 BOTTLE, PLASTIC | SOLUTION | 240 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57237-358-12 | 57237035812 | 120 mL in 1 BOTTLE, PLASTIC (57237-358-12) | 120 ml | 2025-11-11 | No | No | Current |
| 57237-358-24 | 57237035824 | 240 mL in 1 BOTTLE, PLASTIC (57237-358-24) | 240 ml | 2025-11-11 | No | No | Current |