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NDC 43598-0354-78 Lurasidone hydrochloride 80 mg/1 Details
Lurasidone hydrochloride 80 mg/1
Lurasidone hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr. Reddys Laboratories 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: 43598-0354-78Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Lurasidone
Product Information
| NDC | 43598-0354 |
|---|---|
| Product ID | 43598-354_fbf67aef-17be-f29a-d5ac-253d6fe54a91 |
| Associated GPIs | |
| GCN Sequence Number | 066933 |
| GCN Sequence Number Description | lurasidone HCl TABLET 80 MG ORAL |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 29367 |
| HICL Sequence Number | 037321 |
| HICL Sequence Number Description | LURASIDONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Lurasidone hydrochloride |
| 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 | 80 |
| Active Ingredient Units | mg/1 |
| Substance Name | LURASIDONE HYDROCHLORIDE |
| Labeler Name | Dr. Reddys Laboratories Inc |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208047 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43598-0354-78 (43598035478)
| NDC Package Code | 43598-354-78 |
|---|---|
| Billing NDC | 43598035478 |
| Package | 10 BLISTER PACK in 1 CARTON (43598-354-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-354-79) |
| Marketing Start Date | 2023-02-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |