Cetirizine Hydrochloride Tablets,10 mg
- Product NDC
- 51655-842
- 11-digit product format
- 516550842
- Labeler code
- 51655
- Product ID
- 51655-842_4bbb94e5-ada2-ab07-e063-6394a90a1b01
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078933
- Marketing category
- ANDA
- Marketing start
- 2023-02-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride Tablets,10 mg
- Listing expiration
- 2027-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-842-26 | Cetirizine Hydrochloride Tablets,10 mg | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 4 |
| 51655-842-52 | Cetirizine Hydrochloride Tablets,10 mg | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
| 51655-842-60 | Cetirizine Hydrochloride Tablets,10 mg | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 4 |
| 51655-842-84 | Cetirizine Hydrochloride Tablets,10 mg | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-842 | CETIRIZINE HYDROCHLORIDE TABLETS,10 MG (CETIRIZINE HYDROCHLORIDE) TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 4 package rows | 20230420_f756d3b1-d2e4-3705-e053-6294a90aa380.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-842-26 | 51655084226 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-842-26) | 90 tablet | 2023-02-07 | No | No | Historical |
| 51655-842-52 | 51655084252 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-842-52) | 30 tablet | 2023-04-07 | No | No | Historical |
| 51655-842-60 | 51655084260 | 100 TABLET in 1 BOTTLE, PLASTIC (51655-842-60) | 100 tablet | 2023-03-30 | No | No | Historical |
| 51655-842-84 | 51655084284 | 14 TABLET in 1 BOTTLE, PLASTIC (51655-842-84) | 14 tablet | 2023-03-10 | No | No | Historical |