levocetirizine dihydrochloride
- Product NDC
- 68788-7934
- 11-digit product format
- 687887934
- Labeler code
- 68788
- Product ID
- 68788-7934_4b5a138a-e5aa-4f49-a838-0e77480d4534
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA203646
- Marketing category
- ANDA
- Marketing start
- 2021-06-15
- 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 |
|---|
| 68788-7934-1 | levocetirizine dihydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 68788-7934-3 | levocetirizine dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68788-7934-6 | levocetirizine dihydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 68788-7934-9 | levocetirizine dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7934 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240614_8f308352-5854-409e-8bf7-bc9958cc3c5e.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 |
|---|
| 68788-7934-1 | 68788793401 | 100 TABLET in 1 BOTTLE (68788-7934-1) | 100 tablet | 2021-06-15 | 0000-00-00 | No | No | Current |
| 68788-7934-3 | 68788793403 | 30 TABLET in 1 BOTTLE (68788-7934-3) | 30 tablet | 2021-06-15 | 0000-00-00 | No | No | Current |
| 68788-7934-6 | 68788793406 | 60 TABLET in 1 BOTTLE (68788-7934-6) | 60 tablet | 2021-06-15 | 0000-00-00 | No | No | Current |
| 68788-7934-9 | 68788793409 | 90 TABLET in 1 BOTTLE (68788-7934-9) | 90 tablet | 2021-06-15 | 0000-00-00 | No | No | Current |