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NDC 63402-0306-04 Latuda 60 mg/1 Details
Latuda 60 mg/1
Latuda is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sumitomo Pharma America, Inc.. The primary component is LURASIDONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Lurasidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and children 13 years of age and older. It is also used to treat depression in adults and children 10 years of age and older with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Lurasidone is also used along with lithium (Lithobid) or valproate (Depacon) to treat depression in adults with bipolar disorder. Lurasidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Related Packages: 63402-0306-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lurasidone
Product Information
| NDC | 63402-0306 |
|---|---|
| Product ID | 63402-306_538d29c8-d0fe-4a2d-99ad-f16a9a4aa4d2 |
| Associated GPIs | 59400023100330 |
| GCN Sequence Number | 071415 |
| GCN Sequence Number Description | lurasidone HCl TABLET 60 MG ORAL |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 35192 |
| HICL Sequence Number | 037321 |
| HICL Sequence Number Description | LURASIDONE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Latuda |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | lurasidone hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 60 |
| Active Ingredient Units | mg/1 |
| Substance Name | LURASIDONE HYDROCHLORIDE |
| Labeler Name | Sumitomo Pharma America, Inc. |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA200603 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63402-0306-04 (63402030604)
| NDC Package Code | 63402-306-04 |
|---|---|
| Billing NDC | 63402030604 |
| Package | 4 BLISTER PACK in 1 CARTON (63402-306-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-306-07) |
| Marketing Start Date | 2013-07-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |