lurasidone hydrochloride
- Product NDC
- 50090-6438
- 11-digit product format
- 500906438
- Labeler code
- 50090
- Product ID
- 50090-6438_6bf72f5b-ee22-47bb-a052-2bf67dde23a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA208049
- Marketing category
- ANDA
- Marketing start
- 2023-02-20
- 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 |
|---|
| 50090-6438-0 | lurasidone hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6438 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20230427_3cd2da15-4d51-4e5c-b683-1936dc19e234.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6438-0 | 50090643800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6438-0) | 2023-04-17 | No | No | Current |