Lurasidone hydrochloride
- Product NDC
- 70518-4241
- 11-digit product format
- 705184241
- Labeler code
- 70518
- Product ID
- 70518-4241_40077a1f-b3ad-07e2-e063-6394a90a6d2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208047
- Marketing category
- ANDA
- Marketing start
- 2024-12-16
- 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 | 1235247 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4241-0 | Lurasidone hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4241 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20241218_a97b59db-29e8-4b00-9d35-56b47335ee25.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4241-0 | 70518424100 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4241-0) | 2024-12-16 | No | No | Current |