Levocetirizine Dihydrochloride
- Product NDC
- 68071-5107
- 11-digit product format
- 680715107
- Labeler code
- 68071
- Product ID
- 68071-5107_1b469ff6-52ec-a91b-e063-6394a90a3123
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine Dihydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA202046
- Marketing category
- ANDA
- Marketing start
- 2013-09-30
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| SOD6A38AGA | LEVOCETIRIZINE DIHYDROCHLORIDE | 130018-87-0 | LEVOCETIRIZINE DIHYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-5107-9 | 68071510709 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-5107-9) | 2019-11-18 | No | No | Historical |