Cetirizine Hydrochloride
- Product NDC
- 68071-1964
- 11-digit product format
- 680711964
- Labeler code
- 68071
- Product ID
- 68071-1964_1d4bf188-0fd0-b281-e063-6294a90a6ac3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA077829
- Marketing category
- ANDA
- Marketing start
- 2009-10-01
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-1964-1 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-3 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-7 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-9 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-7 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-1 | 2021-04-16 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-3 | 2021-04-16 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-7 | 2021-04-16 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-9 | 2021-04-16 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-7 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
| 68071-1964-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2f79-a910-e053-dadaa90a0b85 | Cetirizine Hydrochloride Tablets, 10 mg, Allergy |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1964-1 | Cetirizine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 5 |
| 68071-1964-3 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68071-1964-7 | Cetirizine Hydrochloride | 7 in 1 BOTTLE | TABLET | 7 | | 5 |
| 68071-1964-9 | 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 |
|---|
| 68071-1964 | CETIRIZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240716_4913192a-7364-3f19-e054-00144ff8d46c.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 |
|---|
| 68071-1964-1 | 68071196401 | 10 TABLET in 1 BOTTLE (68071-1964-1) | 10 tablet | 2017-02-21 | 0000-00-00 | No | No | Current |
| 68071-1964-3 | 68071196403 | 30 TABLET in 1 BOTTLE (68071-1964-3) | 30 tablet | 2017-02-21 | 0000-00-00 | No | No | Current |
| 68071-1964-7 | 68071196407 | 7 TABLET in 1 BOTTLE (68071-1964-7) | 7 tablet | 2017-02-21 | 0000-00-00 | No | No | Current |
| 68071-1964-9 | 68071196409 | 90 TABLET in 1 BOTTLE (68071-1964-9) | 90 tablet | 2017-02-21 | 0000-00-00 | No | No | Current |