Cetirizine Hydrochloride
- Product NDC
- 70000-0047
- 11-digit product format
- 700000047
- Labeler code
- 70000
- Product ID
- 70000-0047_5c5725c9-4879-424d-829c-44017284977a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Allergy
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- LEADER/ CARDINAL HEALTH 110, INC.
- Application
- ANDA090760
- Marketing category
- ANDA
- Marketing start
- 2020-03-26
- 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 |
|---|
| 70000-0047-1 | Cetirizine Hydrochloride | 365 in 1 BOTTLE | TABLET | 365 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0047 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ALLERGY) TABLET [CARDINAL HEALTH] | 3 | Current NDC, Legacy NDC, 1 package rows | 20210617_0cab7aa8-ded3-46f1-b801-2663cc9b0173.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70000-0047-1 | 70000004701 | 365 TABLET in 1 BOTTLE (70000-0047-1) | 365 tablet | 2020-03-26 | 0000-00-00 | No | No | Current |