Lurasidone Hydrochloride
- Product NDC
- 23155-891
- 11-digit product format
- 231550891
- Labeler code
- 23155
- Product ID
- 23155-891_0827fe43-e438-44c3-9962-7491d04b445d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lurasidone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA208058
- Marketing category
- ANDA
- Marketing start
- 2023-10-19
- 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 | 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 |
|---|
| 23155-891-01 | Lurasidone Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 23155-891-03 | Lurasidone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 23155-891-05 | Lurasidone Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
| 23155-891-10 | Lurasidone Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
| 23155-891-18 | Lurasidone Hydrochloride | 20000 in 1 CONTAINER | TABLET, FILM COATED | 20000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-891 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS INC.] | 4 | Current NDC, 5 package rows | 20250323_083a1a52-5a13-4e28-8ef2-127ac4ce5b2d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-891-01 | 23155089101 | 100 TABLET, FILM COATED in 1 BOTTLE (23155-891-01) | 2025-08-20 | No | No | Current |
| 23155-891-03 | 23155089103 | 30 TABLET, FILM COATED in 1 BOTTLE (23155-891-03) | 2025-08-20 | No | No | Current |
| 23155-891-05 | 23155089105 | 500 TABLET, FILM COATED in 1 BOTTLE (23155-891-05) | 2025-08-20 | No | No | Current |
| 23155-891-10 | 23155089110 | 1000 TABLET, FILM COATED in 1 BOTTLE (23155-891-10) | 2025-08-20 | No | No | Current |
| 23155-891-18 | 23155089118 | 20000 TABLET, FILM COATED in 1 CONTAINER (23155-891-18) | 2023-10-19 | No | No | Current |