Lurasidone Hydrochloride
- Product NDC
- 43598-355
- 11-digit product format
- 435980355
- Labeler code
- 43598
- Product ID
- 43598-355_a6742369-fc8f-d7cc-42c1-33c95d6946ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA208055
- Marketing category
- ANDA
- Marketing start
- 2023-02-20
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 120 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 | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O0P4I5851I |
| Rxcui | 1297278 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-355-30 | Lurasidone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-355 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES INC] | 1 | Current NDC, 1 package rows | 20230220_2f22a0bd-94f3-53d7-717c-03da8e1a7e97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-355-30 | 43598035530 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-355-30) | 2023-02-20 | No | No | Current |