LEVOCETIRIZINE DIHYDROCHLORIDE
- Product NDC
- 68788-8810
- 11-digit product format
- 687888810
- Labeler code
- 68788
- Product ID
- 68788-8810_5d6941c7-ef0a-48d3-93dc-53bc2c9789de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA205564
- Marketing category
- ANDA
- Marketing start
- 2025-01-20
- 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 |
|---|
| 68788-8810-1 | LEVOCETIRIZINE DIHYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 68788-8810-3 | LEVOCETIRIZINE DIHYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 68788-8810-6 | LEVOCETIRIZINE DIHYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 68788-8810-9 | 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 |
|---|
| 68788-8810 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 4 package rows | 20250122_5d6941c7-ef0a-48d3-93dc-53bc2c9789de.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8810-1 | 68788881001 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8810-1) | 2025-01-20 | No | No | Current |
| 68788-8810-3 | 68788881003 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8810-3) | 2025-01-20 | No | No | Current |
| 68788-8810-6 | 68788881006 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8810-6) | 2025-01-20 | No | No | Current |
| 68788-8810-9 | 68788881009 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8810-9) | 2025-01-20 | No | No | Current |