Cetirizine Hydrochloride Tablets, 5 mg
- Product NDC
- 25000-219
- 11-digit product format
- 250000219
- Labeler code
- 25000
- Product ID
- 25000-219_cbb30ec0-aba7-4035-8f4a-a3e82b064857
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA078933
- Marketing category
- ANDA
- Marketing start
- 2022-01-13
- 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 Tablets, 5 mg
- 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, 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-219-03 | Cetirizine Hydrochloride Tablets, 5 mg | 1 in 1 CARTON | TABLET | 1 | | 13 |
| 25000-219-03 | Cetirizine Hydrochloride Tablets, 5 mg | 30 in 1 BOTTLE | TABLET | 30 | | 13 |
| 25000-219-08 | Cetirizine Hydrochloride Tablets, 5 mg | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
| 25000-219-08 | Cetirizine Hydrochloride Tablets, 5 mg | 1 in 1 CARTON | TABLET | 1 | | 13 |
| 25000-219-14 | Cetirizine Hydrochloride Tablets, 5 mg | 1000 in 1 BOTTLE | TABLET | 1000 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-219 | CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG (CETIRIZINE HYDROCHLORIDE) TABLET CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG (CETIRIZINE HYDROCHLORIDE) TABLET [MARKSANS PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 5 package rows | 20230823_652b0c65-a3f2-4454-9cf2-51a3389282cc.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 |
|---|
| 25000-219-03 | 25000021903 | 1 BOTTLE in 1 CARTON (25000-219-03) / 30 TABLET in 1 BOTTLE | 1 bottle | 2022-01-13 | 0000-00-00 | No | No | Current |
| 25000-219-08 | 25000021908 | 1 BOTTLE in 1 CARTON (25000-219-08) / 100 TABLET in 1 BOTTLE | 1 bottle | 2022-01-13 | 0000-00-00 | No | No | Current |
| 25000-219-14 | 25000021914 | 1000 TABLET in 1 BOTTLE (25000-219-14) | 1000 tablet | 2022-01-13 | 0000-00-00 | No | No | Current |