Cetirizine hydrochloride
- Product NDC
- 80513-731
- 11-digit product format
- 805130731
- Labeler code
- 80513
- Product ID
- 80513-731_35019a5a-fbea-124b-e063-6394a90a5ec4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- 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 |
|---|
| 80513-731-05 | Cetirizine hydrochloride | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 1 |
| 80513-731-12 | Cetirizine hydrochloride | 120 in 1 BOTTLE | TABLET, COATED | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80513-731 | CETIRIZINE HYDROCHLORIDE TABLET, COATED [ADVANCED RX LLC] | 1 | Current NDC, 2 package rows | 20250515_737492bf-96bd-4f7c-aa42-4910746f44bb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80513-731-05 | 80513073105 | 500 TABLET, COATED in 1 BOTTLE (80513-731-05) | 2025-05-01 | No | No | Historical |
| 80513-731-12 | 80513073112 | 120 TABLET, COATED in 1 BOTTLE (80513-731-12) | 2025-05-01 | No | No | Historical |