Lurasidone Hydrochloride
- Product NDC
- 47335-639
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA208066
- Marketing category
- ANDA
- Substance
- LURASIDONE HYDROCHLORIDE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 47335-639-13 | 500 TABLET in 1 BOTTLE (47335-639-13) | 20230220 | | No | Historical |
| 47335-639-81 | 90 TABLET in 1 BOTTLE (47335-639-81) | 20230220 | | No | Historical |
| 47335-639-83 | 30 TABLET in 1 BOTTLE (47335-639-83) | 20230220 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| 6d97d871-66d3-4ed8-bbc5-0620e9f69ae5 | These highlights do not include all the information needed to use LURASIDONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LURASIDONE HYDROCHLORIDE TABLETS. LURASIDONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2010 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2025-02-24 | Human Prescription Drug Label | 7 |