Cetirizine Hydrochloride (Allergy)
- Product NDC
- 68001-436
- 11-digit product format
- 680010436
- Labeler code
- 68001
- Product ID
- 68001-436_4262085e-1de6-302e-e063-6394a90a0026
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA090760
- Marketing category
- ANDA
- Marketing start
- 2020-06-19
- 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 (Allergy)
- 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 |
|---|
| 68001-436-04 | Cetirizine Hydrochloride (Allergy) | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68001-436-04 | Cetirizine Hydrochloride (Allergy) | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 68001-436-16 | Cetirizine Hydrochloride (Allergy) | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
| 68001-436-96 | Cetirizine Hydrochloride (Allergy) | 10 in 1 CARTON | TABLET | 10 | | 5 |
| 68001-436-97 | Cetirizine Hydrochloride (Allergy) | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 68001-436-97 | Cetirizine Hydrochloride (Allergy) | 300 in 1 BOTTLE | TABLET | 300 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-436 | CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [BLUEPOINT LABORATORIES] | 3 | Current NDC, Legacy NDC, 6 package rows | 20240322_a86fbe45-08db-bddf-e053-2a95a90aa792.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 |
|---|
| 68001-436-04 | 68001043604 | 1 BOTTLE in 1 CARTON (68001-436-04) / 30 TABLET in 1 BOTTLE | 1 bottle | 2020-06-19 | 0000-00-00 | No | No | Current |
| 68001-436-16 | 68001043616 | 10 TABLET in 1 BLISTER PACK (68001-436-16) | 10 tablet | 2020-06-19 | 0000-00-00 | No | No | Current |
| 68001-436-96 | 68001043696 | 10 BLISTER PACK in 1 CARTON (68001-436-96) / 10 TABLET in 1 BLISTER PACK (68001-436-16) | 10 blister pack | 2020-06-19 | 0000-00-00 | No | No | Current |
| 68001-436-97 | 68001043697 | 1 BOTTLE in 1 CARTON (68001-436-97) / 300 TABLET in 1 BOTTLE | 1 bottle | 2020-06-19 | 0000-00-00 | No | No | Current |