Lurasidone hydrochloride
- Product NDC
- 43598-353
- 11-digit product format
- 435980353
- Labeler code
- 43598
- Product ID
- 43598-353_f3c17d88-383d-89de-d8d6-8ed1bb1b3750
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA208047
- Marketing category
- ANDA
- Marketing start
- 2023-02-20
- 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 | 1040031, 1040041, 1235247, 1431235 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-353-05 | Lurasidone hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 13 |
| 43598-353-30 | Lurasidone hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 43598-353-78 | Lurasidone hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 13 |
| 43598-353-79 | Lurasidone hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 13 |
| 43598-353-90 | Lurasidone hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-353 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES INC] | 13 | Current NDC, 5 package rows | 20250402_9b512af1-98ab-1242-10e8-9534a002306e.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 |
|---|
| 43598-353-05 | 43598035305 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-353-05) | | 2023-02-20 | No | No | Current |
| 43598-353-30 | 43598035330 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-353-30) | | 2023-02-20 | No | No | Current |
| 43598-353-78 | 43598035378 | 10 BLISTER PACK in 1 CARTON (43598-353-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-353-79) | 10 blister pack | 2023-02-20 | No | No | Current |
| 43598-353-79 | 43598035379 | 10 in 1 BLISTER PACK | | | | | Historical |
| 43598-353-90 | 43598035390 | 90 TABLET, FILM COATED in 1 BOTTLE (43598-353-90) | | 2023-02-20 | No | No | Current |