Lurasidone Hydrochloride
- Product NDC
- 47335-684
- 11-digit product format
- 473350684
- Labeler code
- 47335
- Product ID
- 47335-684_2ebf334e-6f66-4ef7-b0ca-9d21ccb3165e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA208066
- Marketing category
- ANDA
- Marketing start
- 2023-02-20
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 40 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LURASIDONE HYDROCHLORIDE | 40 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 |
|---|
| 47335-684-13 | Lurasidone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
| 47335-684-81 | Lurasidone Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
| 47335-684-83 | Lurasidone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-684 | LURASIDONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 7 | Current NDC, 3 package rows | 20250306_6d97d871-66d3-4ed8-bbc5-0620e9f69ae5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 47335-684-13 | 47335068413 | 500 TABLET in 1 BOTTLE (47335-684-13) | 500 tablet | 2023-02-20 | No | No | Current |
| 47335-684-81 | 47335068481 | 90 TABLET in 1 BOTTLE (47335-684-81) | 90 tablet | 2023-02-20 | No | No | Current |
| 47335-684-83 | 47335068483 | 30 TABLET in 1 BOTTLE (47335-684-83) | 30 tablet | 2023-02-20 | No | No | Current |