levocetirizine dihydrochloride
- Product NDC
- 51655-564
- 11-digit product format
- 516550564
- Labeler code
- 51655
- Product ID
- 51655-564_4b4903ae-48bd-d41a-e063-6294a90ac4ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA203646
- Marketing category
- ANDA
- Marketing start
- 2021-01-25
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- 5 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
- levocetirizine dihydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOD6A38AGA |
| Rxcui | 855172 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-564-52 | levocetirizine dihydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-564 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20230413_dae403cd-b6fc-7c50-e053-2995a90a95e3.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 |
|---|
| 51655-564-52 | 51655056452 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-564-52) | 30 tablet | 2021-01-25 | No | No | Historical |