Cetirizine Hydrochloride
- Product NDC
- 69848-006
- 11-digit product format
- 698480006
- Labeler code
- 69848
- Product ID
- 69848-006_468e40c3-a669-29bd-e063-6394a90a8812
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules USA, Inc.
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2021-06-30
- 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 |
|---|
| 69848-006-09 | Cetirizine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69848-006 | CETIRIZINE HYDROCHLORIDE TABLET [GRANULES USA, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241212_c8d711cd-7214-c7d5-e053-2995a90a6b67.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 |
|---|
| 69848-006-09 | 69848000609 | 90 TABLET in 1 BOTTLE (69848-006-09) | 90 tablet | 2021-06-30 | 0000-00-00 | No | No | Current |