lurasidone hydrochloride
- Product NDC
- 67877-642
- 11-digit product format
- 678770642
- Labeler code
- 67877
- Product ID
- 67877-642_6e4065a5-2672-4ef4-996d-f9d2f58970d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA212244
- Marketing category
- ANDA
- Marketing start
- 2023-01-04
- 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 |
|---|
| 67877-642-05 | lurasidone hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 67877-642-30 | lurasidone hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 67877-642-33 | lurasidone hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
| 67877-642-38 | lurasidone hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 8 |
| 67877-642-90 | lurasidone hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-642 | LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 8 | Current NDC, Legacy NDC, 5 package rows | 20230107_36b6bacd-ac11-493b-a8a4-8dad448ed9d5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-642-05 | 67877064205 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-642-05) | | 2023-01-04 | 0000-00-00 | No | No | Current |
| 67877-642-30 | 67877064230 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-642-30) | | 2023-01-04 | 0000-00-00 | No | No | Current |
| 67877-642-33 | 67877064233 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 67877-642-38 | 67877064238 | 10 BLISTER PACK in 1 CARTON (67877-642-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-642-33) | 10 blister pack | 2023-01-04 | 0000-00-00 | No | No | Current |
| 67877-642-90 | 67877064290 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-642-90) | | 2023-01-04 | 0000-00-00 | No | No | Current |