Cetirizine
- Product NDC
- 51316-764
- 11-digit product format
- 513160764
- Labeler code
- 51316
- Product ID
- 51316-764_465428ca-3000-a730-e063-6394a90a1af4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetiirizine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2023-10-16
- 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
- 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 |
|---|
| 51316-764-65 | Cetirizine | 365 in 1 BOTTLE | TABLET | 365 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-764 | CETIRIZINE (CETIIRIZINE) TABLET [CVS PHARMACY, INC] | 4 | Current NDC, 1 package rows | 20241120_fd8f495a-9940-363b-e053-6294a90a1097.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 |
|---|
| 51316-764-65 | 51316076465 | 365 TABLET in 1 BOTTLE (51316-764-65) | 365 tablet | 2023-10-16 | No | No | Current |