Lurasidone hydrochloride
- Product NDC
- 70771-1737
- 11-digit product format
- 707711737
- Labeler code
- 70771
- Product ID
- 70771-1737_b82674a0-84e9-4431-9041-e5c360bbdaca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA208052
- Marketing category
- ANDA
- Marketing start
- 2023-02-01
- 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 |
|---|
| 70771-1737-1 | Lurasidone hydrochloride | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 4 |
| 70771-1737-2 | Lurasidone hydrochloride | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 4 |
| 70771-1737-3 | Lurasidone hydrochloride | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 4 |
| 70771-1737-4 | Lurasidone hydrochloride | 10 in 1 CARTON | TABLET, COATED | 10 | | 4 |
| 70771-1737-5 | Lurasidone hydrochloride | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 4 |
| 70771-1737-9 | Lurasidone hydrochloride | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1737 | LURASIDONE HYDROCHLORIDE TABLET, COATED [ZYDUS LIFESCIENCES LIMITED] | 4 | Current NDC, 6 package rows | 20241204_0f5f8228-1304-4981-8577-029136627260.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1737-1 | 70771173701 | 100 TABLET, COATED in 1 BOTTLE (70771-1737-1) | | 2023-02-01 | No | No | Historical |
| 70771-1737-2 | 70771173702 | 10 in 1 BLISTER PACK | | | | | Historical |
| 70771-1737-3 | 70771173703 | 30 TABLET, COATED in 1 BOTTLE (70771-1737-3) | | 2023-02-01 | No | No | Historical |
| 70771-1737-4 | 70771173704 | 10 BLISTER PACK in 1 CARTON (70771-1737-4) / 10 TABLET, COATED in 1 BLISTER PACK (70771-1737-2) | 10 blister pack | 2023-02-01 | No | No | Historical |
| 70771-1737-5 | 70771173705 | 500 TABLET, COATED in 1 BOTTLE (70771-1737-5) | | 2023-02-01 | No | No | Historical |
| 70771-1737-9 | 70771173709 | 90 TABLET, COATED in 1 BOTTLE (70771-1737-9) | | 2023-02-01 | No | No | Historical |