Cetirizine Hydrochloride Tablets,10 mg
- Product NDC
- 49483-692
- 11-digit product format
- 494830692
- Labeler code
- 49483
- Product ID
- 49483-692_12f9d89b-5334-1339-e063-6394a90ad0e8
- 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
- 2022-02-12
- 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 Tablets,10 mg
- 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 |
|---|
| 49483-692-01 | Cetirizine Hydrochloride Tablets,10 mg | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 49483-692-20 | Cetirizine Hydrochloride Tablets,10 mg | 200 in 1 BOTTLE | TABLET | 200 | | 5 |
| 49483-692-50 | Cetirizine Hydrochloride Tablets,10 mg | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
| 49483-692-65 | Cetirizine Hydrochloride Tablets,10 mg | 365 in 1 BOTTLE | TABLET | 365 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-692 | CETIRIZINE HYDROCHLORIDE TABLETS,10 MG (CETIRIZINE HYDROCHLORIDE) TABLET [TIME CAP LABORATORIES, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240307_d78223ba-80d5-47f8-e053-2a95a90aebdb.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 |
|---|
| 49483-692-01 | 49483069201 | 100 TABLET in 1 BOTTLE (49483-692-01) | 100 tablet | 2024-03-11 | | No | No | Current |
| 49483-692-20 | 49483069220 | 200 TABLET in 1 BOTTLE (49483-692-20) | 200 tablet | 2024-03-11 | | No | No | Current |
| 49483-692-31 | 49483069231 | 300 TABLET in 1 BOTTLE (49483-692-31) | 300 tablet | 2022-05-30 | 0000-00-00 | No | No | Current |
| 49483-692-50 | 49483069250 | 500 TABLET in 1 BOTTLE (49483-692-50) | 500 tablet | 2022-05-30 | 0000-00-00 | No | No | Current |
| 49483-692-65 | 49483069265 | 365 TABLET in 1 BOTTLE (49483-692-65) | 365 tablet | 2022-02-12 | 0000-00-00 | No | No | Current |