Latuda
- Product NDC
- 63402-308
- 11-digit product format
- 634020308
- Labeler code
- 63402
- Product ID
- 63402-308_7383b0e0-01e8-4778-96f0-6f2e0c9586ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lurasidone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sumitomo Pharma America, Inc.
- Application
- NDA200603
- Marketing category
- NDA
- Marketing start
- 2010-10-28
- Substance
- LURASIDONE HYDROCHLORIDE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Latuda
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LURASIDONE HYDROCHLORIDE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O0P4I5851I |
| Rxcui | 1040031, 1040036, 1040041, 1040043, 1235247, 1235249, 1297278, 1297357, 1431235, 1431237 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63402-308-01 | Latuda | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 37 |
| 63402-308-04 | Latuda | 4 in 1 CARTON | TABLET, FILM COATED | 4 | | 37 |
| 63402-308-07 | Latuda | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 37 |
| 63402-308-10 | Latuda | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 37 |
| 63402-308-30 | Latuda | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 37 |
| 63402-308-50 | Latuda | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 37 |
| 63402-308-90 | Latuda | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 37 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| lurasidone hydrochloride | ACTIVE INGREDIENT | O0P4I5851I | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| lurasidone | ACTIVE MOIETY | 22IC88528T | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| Carnauba Wax | INACTIVE INGREDIENT | R12CBM0EIZ | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| FD&C blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| hypromellose 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63402-308 | LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.] | 36 | Current NDC, Legacy NDC, 7 package rows | 20250206_afad3051-9df2-4c54-9684-e8262a133af8.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 |
|---|
| 63402-308-01 | 63402030801 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 63402-308-04 | 63402030804 | 4 BLISTER PACK in 1 CARTON (63402-308-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-308-07) | 4 blister pack | 2010-10-28 | 0000-00-00 | No | No | Current |
| 63402-308-07 | 63402030807 | 7 in 1 BLISTER PACK | | | | | | Historical |
| 63402-308-10 | 63402030810 | 10 BLISTER PACK in 1 CARTON (63402-308-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-308-01) | 10 blister pack | 2010-10-28 | 0000-00-00 | No | No | Current |
| 63402-308-30 | 63402030830 | 30 TABLET, FILM COATED in 1 BOTTLE (63402-308-30) | | 2010-10-28 | 0000-00-00 | No | No | Current |
| 63402-308-50 | 63402030850 | 500 TABLET, FILM COATED in 1 BOTTLE (63402-308-50) | | 2010-10-28 | 0000-00-00 | No | No | Current |
| 63402-308-90 | 63402030890 | 90 TABLET, FILM COATED in 1 BOTTLE (63402-308-90) | | 2010-10-28 | 0000-00-00 | No | No | Current |