Lurasidone Hydrochloride
- Product NDC
- 53746-082
- 11-digit product format
- 537460082
- Labeler code
- 53746
- Product ID
- 53746-082_f81d4ba1-6578-46ad-bbc6-7c80a6e37625
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA208002
- Marketing category
- ANDA
- Marketing start
- 2024-07-05
- 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 |
|---|
| 53746-082-30 | Lurasidone Hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-082 | LURASIDONE HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 2 | Current NDC, 1 package rows | 20240706_84648adf-b3c6-476e-8d11-2a9d7c5eb550.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 53746-082-30 | 53746008230 | 30 TABLET, COATED in 1 BOTTLE (53746-082-30) | 2024-07-05 | No | No | Historical |