lurasidone hydrochloride
- Product NDC
- 16729-348
- 11-digit product format
- 167290348
- Labeler code
- 16729
- Product ID
- 16729-348_415fe396-0d31-40a9-e063-6294a90a8462
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA208049
- 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, 1297278, 1431235 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-348-10 | lurasidone hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 16729-348-15 | lurasidone hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
| 16729-348-16 | lurasidone hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
| 16729-348-17 | lurasidone hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 7 |
| 16729-348-45 | lurasidone hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 7 |
| 16729-348-46 | lurasidone hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-348 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 6 | Current NDC, 6 package rows | 20241006_7e11ec22-63c1-41a6-899c-4fe746f76bd0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 16729-348-10 | 16729034810 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-348-10) | 2023-02-20 | No | No | Current |
| 16729-348-15 | 16729034815 | 90 in 1 BOTTLE | | | | Historical |
| 16729-348-16 | 16729034816 | 500 in 1 BOTTLE | | | | Historical |
| 16729-348-17 | 16729034817 | 1000 in 1 BOTTLE | | | | Historical |
| 16729-348-45 | 16729034845 | 10 in 1 BLISTER PACK | | | | Historical |
| 16729-348-46 | 16729034846 | 10 in 1 CARTON | | | | Historical |