Cetirizine Hydrochloride
- Product NDC
- 85293-001
- 11-digit product format
- 852930001
- Labeler code
- 85293
- Product ID
- 85293-001_2fb2f0c8-a45a-5c2a-e063-6394a90a1587
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Umasuto, LLC
- Application
- ANDA077829
- Marketing category
- ANDA
- Marketing start
- 2025-03-04
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85293-001-01 | Cetirizine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85293-001 | CETIRIZINE HYDROCHLORIDE TABLET [UMASUTO, LLC] | 1 | Current NDC, 1 package rows | 20250313_9af4ab23-d6d3-43f9-a026-76fd9771963f.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 |
|---|
| 85293-001-01 | 85293000101 | 100 TABLET in 1 BOTTLE (85293-001-01) | 100 tablet | 2025-03-04 | No | No | Historical |