Lurasidone Hydrochloride
- Product NDC
- 46708-497
- 11-digit product format
- 467080497
- Labeler code
- 46708
- Product ID
- 46708-497_a4f0715d-590f-4b13-bb72-19cdca95aa01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA213248
- Marketing category
- ANDA
- Marketing start
- 2023-01-24
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 80 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 | 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 |
|---|
| 46708-497-10 | Lurasidone Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 3 |
| 46708-497-10 | Lurasidone Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 3 |
| 46708-497-30 | Lurasidone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 46708-497-71 | Lurasidone Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 46708-497-90 | Lurasidone Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 46708-497-91 | Lurasidone Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-497 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 6 package rows | 20230126_27f70e15-ee22-47ae-ba87-20e2b4a1a4d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-497-10 | 46708049710 | 100 BLISTER PACK in 1 CARTON (46708-497-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2023-01-24 | 0000-00-00 | No | No | Current |
| 46708-497-30 | 46708049730 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-497-30) | | 2023-01-24 | 0000-00-00 | No | No | Current |
| 46708-497-71 | 46708049771 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-497-71) | | 2023-01-24 | 0000-00-00 | No | No | Current |
| 46708-497-90 | 46708049790 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-497-90) | | 2023-01-24 | 0000-00-00 | No | No | Current |
| 46708-497-91 | 46708049791 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-497-91) | | 2023-01-24 | 0000-00-00 | No | No | Current |