Cetirizine Hydrochloride
- Product NDC
- 85766-045
- 11-digit product format
- 857660045
- Labeler code
- 85766
- Product ID
- 85766-045_4a2c3f01-e8a9-c309-e063-6294a90a61e8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2018-12-17
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- Listing expiration
- 2027-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-045-05 | Cetirizine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-045-05 | 85766004505 | 500 TABLET, FILM COATED in 1 BOTTLE (85766-045-05) | 2025-08-02 | No | No | Historical |