Lurasidone Hydrochloride
- Product NDC
- 65162-082
- 11-digit product format
- 651620082
- Labeler code
- 65162
- Product ID
- 65162-082_cfb63983-dd01-4006-b387-7e8cfec0699d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA208002
- Marketing category
- ANDA
- Marketing start
- 2023-01-02
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 60 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 | 60 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 |
|---|
| 65162-082-03 | Lurasidone Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 15 |
| 65162-082-09 | Lurasidone Hydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 15 |
| 65162-082-50 | Lurasidone Hydrochloride | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-082 | LURASIDONE HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS LLC] | 15 | Current NDC, Legacy NDC, 3 package rows | 20250417_6ef0b2f9-9356-4f61-a2fa-e7c2c77a5d3a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-082-03 | 65162008203 | 30 TABLET, COATED in 1 BOTTLE (65162-082-03) | 2023-01-02 | 0000-00-00 | No | No | Current |
| 65162-082-09 | 65162008209 | 90 TABLET, COATED in 1 BOTTLE (65162-082-09) | 2023-01-02 | 0000-00-00 | No | No | Current |
| 65162-082-50 | 65162008250 | 500 TABLET, COATED in 1 BOTTLE (65162-082-50) | 2023-01-02 | 0000-00-00 | No | No | Current |