Lurasidone Hydrochloride
- Product NDC
- 13668-466
- 11-digit product format
- 136680466
- Labeler code
- 13668
- Product ID
- 13668-466_e535c6d5-718e-489b-ad51-7d34dfabcec5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA208055
- Marketing category
- ANDA
- Marketing start
- 2019-01-03
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | 80 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 |
|---|
| 13668-466-30 | Lurasidone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 13668-466-90 | Lurasidone Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-466 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250509_9cb5e275-1029-407a-8c93-ec5cde2d323b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-466-05 | 13668046605 | 500 TABLET, FILM COATED in 1 BOTTLE (13668-466-05) | 2018-12-28 | 0000-00-00 | No | No | Current |
| 13668-466-30 | 13668046630 | 30 TABLET, FILM COATED in 1 BOTTLE (13668-466-30) | 2019-01-03 | 0000-00-00 | No | No | Current |
| 13668-466-74 | 13668046674 | 100 TABLET, FILM COATED in 1 BLISTER PACK (13668-466-74) | 2018-12-28 | 0000-00-00 | No | No | Current |
| 13668-466-90 | 13668046690 | 90 TABLET, FILM COATED in 1 BOTTLE (13668-466-90) | 2019-01-03 | 0000-00-00 | No | No | Current |