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NDC 68382-0446-01 Bosentan 62.5 mg/1 Details
Bosentan 62.5 mg/1
Bosentan is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is BOSENTAN.
MedlinePlus Drug Summary
Bosentan is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) in adults and children 3 years of age and older. Bosentan may improve the ability to exercise and slow the worsening of symptoms in patients with PAH. Bosentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.
Related Packages: 68382-0446-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bosentan
Product Information
| NDC | 68382-0446 |
|---|---|
| Product ID | 68382-446_a8ee488d-716d-48e1-b150-4345366166ca |
| Associated GPIs | 40160015000320 |
| GCN Sequence Number | 048988 |
| GCN Sequence Number Description | bosentan TABLET 62.5 MG ORAL |
| HIC3 | B1B |
| HIC3 Description | PULMONARY ANTI-HTN, ENDOTHELIN RECEPTOR ANTAGONIST |
| GCN | 14979 |
| HICL Sequence Number | 022990 |
| HICL Sequence Number Description | BOSENTAN |
| Brand/Generic | Generic |
| Proprietary Name | Bosentan |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bosentan |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 62.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | BOSENTAN |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207760 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0446-01 (68382044601)
| NDC Package Code | 68382-446-01 |
|---|---|
| Billing NDC | 68382044601 |
| Package | 100 TABLET, COATED in 1 BOTTLE (68382-446-01) |
| Marketing Start Date | 2019-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |