Lurasidone Hydrochloride
- Product NDC
- 62332-494
- 11-digit product format
- 623320494
- Labeler code
- 62332
- Product ID
- 62332-494_2ad2918d-7142-4425-bd00-45a269ef0d61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA213248
- Marketing category
- ANDA
- Marketing start
- 2023-01-24
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lurasidone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LURASIDONE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O0P4I5851I |
| Rxcui | 1040031, 1040041, 1235247, 1297278, 1431235 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-494-10 | Lurasidone Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 8 |
| 62332-494-10 | Lurasidone Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
| 62332-494-30 | Lurasidone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 62332-494-71 | Lurasidone Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 62332-494-90 | Lurasidone Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
| 62332-494-91 | Lurasidone Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-494 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 6 package rows | 20250427_1cc441b3-0a23-4c68-a90e-436030b7daf2.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 |
|---|
| 62332-494-10 | 62332049410 | 100 BLISTER PACK in 1 CARTON (62332-494-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2023-01-24 | 0000-00-00 | No | No | Current |
| 62332-494-30 | 62332049430 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-494-30) | | 2023-01-24 | 0000-00-00 | No | No | Current |
| 62332-494-71 | 62332049471 | 500 TABLET, FILM COATED in 1 BOTTLE (62332-494-71) | | 2023-01-24 | 0000-00-00 | No | No | Current |
| 62332-494-90 | 62332049490 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-494-90) | | 2023-01-24 | 0000-00-00 | No | No | Current |
| 62332-494-91 | 62332049491 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-494-91) | | 2023-01-24 | 0000-00-00 | No | No | Current |