Levocetirizine Dihydrochloride
- Product NDC
- 68071-3726
- 11-digit product format
- 680713726
- Labeler code
- 68071
- Product ID
- 68071-3726_27878da9-3e05-df72-e063-6394a90a378b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA090199
- Marketing category
- ANDA
- Marketing start
- 2011-09-06
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levocetirizine Dihydrochloride
- Listing expiration
- 2026-12-31
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 |
|---|
| 68071-3726-9 | Levocetirizine Dihydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3726 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20241124_2787aaa2-5209-f7d5-e063-6294a90a7103.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3726-9 | 68071372609 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3726-9) | 2024-11-22 | No | No | Current |