lurasidone hydrochloride
- Product NDC
- 0904-7422
- 11-digit product format
- 009047422
- Labeler code
- 0904
- Product ID
- 0904-7422_cecfd4c8-bff3-44fa-b360-b3e8a8e955f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MAJOR PHARMACEUTICALS
- Application
- ANDA208037
- Marketing category
- ANDA
- Marketing start
- 2023-02-09
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 40 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 | 40 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 |
|---|
| 0904-7422-46 | 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 |
|---|
| 0904-7422 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20240107_cecfd4c8-bff3-44fa-b360-b3e8a8e955f5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7422-46 | 00904742246 | 30 TABLET, FILM COATED in 1 BOTTLE (0904-7422-46) | 2024-01-05 | No | No | Historical |