Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)
- Product NDC
- 25000-160
- 11-digit product format
- 250000160
- Labeler code
- 25000
- Product ID
- 25000-160_cbb30ec0-aba7-4035-8f4a-a3e82b064857
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA078933
- Marketing category
- ANDA
- Marketing start
- 2025-04-10
- 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 Tablets, 10 mg (Oval Shape)
- 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 | 1014676, 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-160-03 | Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) | 1 in 1 CARTON | TABLET | 1 | | 13 |
| 25000-160-03 | Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) | 30 in 1 BOTTLE | TABLET | 30 | | 13 |
| 25000-160-14 | Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) | 1000 in 1 BOTTLE | TABLET | 1000 | | 13 |
| 25000-160-81 | Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) | 14 in 1 BLISTER PACK | TABLET | 14 | | 13 |
| 25000-160-81 | Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) | 1 in 1 CARTON | TABLET | 1 | | 13 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25000-160-03 | 25000016003 | 1 BOTTLE in 1 CARTON (25000-160-03) / 30 TABLET in 1 BOTTLE | 1 bottle | 2025-04-10 | No | No | Current |
| 25000-160-14 | 25000016014 | 1000 TABLET in 1 BOTTLE (25000-160-14) | 1000 tablet | 2025-04-10 | No | No | Current |
| 25000-160-81 | 25000016081 | 1 BLISTER PACK in 1 CARTON (25000-160-81) / 14 TABLET in 1 BLISTER PACK | 1 blister pack | 2025-04-10 | No | No | Current |