Cetirizine Hydrochloride
- Product NDC
- 49483-682
- 11-digit product format
- 494830682
- Labeler code
- 49483
- Product ID
- 49483-682_dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC.
- Application
- ANDA078933
- Marketing category
- ANDA
- Marketing start
- 2022-05-30
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014676 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-682-01 | Cetirizine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-682 | CETIRIZINE HYDROCHLORIDE TABLET [TIME CAP LABORATORIES, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20220530_dfbddafb-9455-5805-e053-2a95a90ad0d9.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 |
|---|
| 49483-682-01 | 49483068201 | 100 TABLET in 1 BOTTLE (49483-682-01) | 100 tablet | 2022-05-30 | 0000-00-00 | No | No | Current |