lurasidone hydrochloride
- Product NDC
- 0904-7359
- 11-digit product format
- 009047359
- Labeler code
- 0904
- Product ID
- 0904-7359_382b3af6-5685-44e2-b310-76fee0d2e0da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA212244
- Marketing category
- ANDA
- Marketing start
- 2023-01-04
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [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 |
|---|
| O0P4I5851I | LURASIDONE HYDROCHLORIDE | 367514-88-3 | LURASIDONE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7359-04 | 00904735904 | 30 BLISTER PACK in 1 CARTON (0904-7359-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2023-02-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| lurasidone hydrochloride | Major Pharmaceuticals | 2025-09-11 | HUMAN PRESCRIPTION DRUG LABEL | 5 |