CETIRIZINE HYDROCHLORIDE
- Product NDC
- 55681-073
- 11-digit product format
- 556810073
- Labeler code
- 55681
- Product ID
- 55681-073_4e69476d-dee2-dac7-e063-6294a90a06d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETIRIZINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TWIN MED, LLC
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2022-03-02
- 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 |
|---|
| 55681-073-03 | CETIRIZINE HYDROCHLORIDE | 300 in 1 BOTTLE | TABLET | 300 | | 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 |
|---|
| 55681-073-03 | 55681007303 | 300 TABLET in 1 BOTTLE (55681-073-03) | 300 tablet | 2026-04-01 | No | No | Current |