lurasidone hydrochloride
- Product NDC
- 68180-674
- 11-digit product format
- 681800674
- Labeler code
- 68180
- Product ID
- 68180-674_8d77b0dd-8cc2-44da-afed-1e5cb75bed99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lurasidone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA208031
- Marketing category
- ANDA
- Marketing start
- 2023-02-20
- 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
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 | 120 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 |
|---|
| 68180-674-06 | lurasidone hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-674 | LURASIDONE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 13 | Current NDC, 1 package rows | 20250302_74f2429b-71df-47f0-9cb5-98685372a9b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-674-06 | 68180067406 | 30 TABLET in 1 BOTTLE (68180-674-06) | 30 tablet | 2023-02-20 | No | No | Historical |