Cetirizine hydrochloride
- Product NDC
- 37835-611
- 11-digit product format
- 378350611
- Labeler code
- 37835
- Product ID
- 37835-611_36d0b7f3-2156-873a-e063-6294a90ac015
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bi-Mar
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- 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 |
|---|
| 37835-611-14 | Cetirizine hydrochloride | 14 in 1 BOTTLE | TABLET | 14 | | 1 |
| 37835-611-35 | Cetirizine hydrochloride | 35 in 1 BOTTLE | TABLET | 35 | | 1 |
| 37835-611-90 | Cetirizine hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 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 |
|---|
| 37835-611-14 | 37835061114 | 14 TABLET in 1 BOTTLE (37835-611-14) | 14 tablet | 2025-05-01 | No | No | Current |
| 37835-611-35 | 37835061135 | 35 TABLET in 1 BOTTLE (37835-611-35) | 35 tablet | 2025-05-01 | No | No | Current |
| 37835-611-90 | 37835061190 | 90 TABLET in 1 BOTTLE (37835-611-90) | 90 tablet | 2025-05-01 | No | No | Current |