Cetirizine Hydrochloride (Allergy)
- Product NDC
- 16714-799
- 11-digit product format
- 167140799
- Labeler code
- 16714
- Product ID
- 16714-799_31542c85-db9e-4225-bd25-d231710595b0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA090760
- Marketing category
- ANDA
- Marketing start
- 2015-08-05
- 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 |
|---|
| 16714-799-01 | Cetirizine Hydrochloride (Allergy) | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 16714-799-02 | Cetirizine Hydrochloride (Allergy) | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 16714-799-03 | Cetirizine Hydrochloride (Allergy) | 300 in 1 BOTTLE | TABLET | 300 | | 4 |
| 16714-799-04 | Cetirizine Hydrochloride (Allergy) | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-799 | CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [NORTHSTAR RX LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240628_c9d1e26f-c95a-4991-95fa-9ed6ed484fe2.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 |
|---|
| 16714-799-01 | 16714079901 | 30 TABLET in 1 BOTTLE (16714-799-01) | 30 tablet | 2015-08-05 | 0000-00-00 | No | No | Current |
| 16714-799-02 | 16714079902 | 100 TABLET in 1 BOTTLE (16714-799-02) | 100 tablet | 2015-08-05 | 0000-00-00 | No | No | Current |
| 16714-799-03 | 16714079903 | 300 TABLET in 1 BOTTLE (16714-799-03) | 300 tablet | 2015-08-05 | 0000-00-00 | No | No | Current |
| 16714-799-04 | 16714079904 | 500 TABLET in 1 BOTTLE (16714-799-04) | 500 tablet | 2015-08-05 | 0000-00-00 | No | No | Current |