Lurasidone hydrochloride
- Product NDC
- 13668-509
- 11-digit product format
- 136680509
- Labeler code
- 13668
- Product ID
- 13668-509_dba1819d-0cd5-4522-9666-5155aa9e0085
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA208047
- Marketing category
- ANDA
- Marketing start
- 2023-02-17
- 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 | 1431235 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-509-30 | Lurasidone hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-509 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED] | 4 | Current NDC, 1 package rows | 20250418_a101e62e-dd1f-4add-8393-ba6d54adce06.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 13668-509-30 | 13668050930 | 30 TABLET, FILM COATED in 1 BOTTLE (13668-509-30) | 2023-02-17 | No | No | Current |