Levocetirizine Dihydrochloride
- Product NDC
- 68788-7699
- 11-digit product format
- 687887699
- Labeler code
- 68788
- Product ID
- 68788-7699_59e08960-95db-4059-9817-ce56f60040b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine Dihydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA202046
- Marketing category
- ANDA
- Marketing start
- 2020-04-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7699 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 5 | Legacy NDC | 20240613_30bf11cc-cf60-441f-9eea-6dfbe740923e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7699-1 | 68788769901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7699-1) | 2020-04-01 | 0000-00-00 | No | No | Current |
| 68788-7699-3 | 68788769903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7699-3) | 2020-04-02 | 0000-00-00 | No | No | Current |
| 68788-7699-6 | 68788769906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7699-6) | 2020-04-01 | 0000-00-00 | No | No | Current |
| 68788-7699-9 | 68788769909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7699-9) | 2020-04-01 | 0000-00-00 | No | No | Current |