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NDC 00456-2405-10 SAPHRIS 5 mg/1 Details
SAPHRIS 5 mg/1
SAPHRIS is a SUBLINGUAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Allergan, Inc.. The primary component is ASENAPINE MALEATE.
MedlinePlus Drug Summary
Asenapine 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). Asenapine is used alone or in combination with other medications to treat or prevent episodes of mania (frenzied, abnormally excited mood) or mixed mania (frenzied, abnormally excited mood and symptoms of depression) in adults and children 10 years of age and older with bipolar I disorder (manic depressive disorder; a disease that causes episodes of mania, episodes of depression and other abnormal moods). Asenapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Related Packages: 00456-2405-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Asenapine
Product Information
| NDC | 00456-2405 |
|---|---|
| Product ID | 0456-2405_251a0ca6-0449-472c-871c-2c3f3be60d92 |
| Associated GPIs | 59155015100720 |
| GCN Sequence Number | 065537 |
| GCN Sequence Number Description | asenapine maleate TAB SUBL 5 MG SUBLINGUAL |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 21636 |
| HICL Sequence Number | 036576 |
| HICL Sequence Number Description | ASENAPINE MALEATE |
| Brand/Generic | Brand |
| Proprietary Name | SAPHRIS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Asenapine Maleate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | SUBLINGUAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | ASENAPINE MALEATE |
| Labeler Name | Allergan, Inc. |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022117 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00456-2405-10 (00456240510)
| NDC Package Code | 0456-2405-10 |
|---|---|
| Billing NDC | 00456240510 |
| Package | 1 CASE in 1 CARTON (0456-2405-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2013-09-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |