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NDC 60505-4553-03 Ambrisentan 10 mg/1 Details
Ambrisentan 10 mg/1
Ambrisentan is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is AMBRISENTAN.
MedlinePlus Drug Summary
Ambrisentan is used alone or in combination with tadalafil (Adcirca, Cialis) to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs). Ambrisentan may improve the ability to exercise and slow the worsening of symptoms in people with PAH. Ambrisentan 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: 60505-4553-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ambrisentan
Product Information
| NDC | 60505-4553 |
|---|---|
| Product ID | 60505-4553_ac315931-07c2-84f0-5a22-cd422464e943 |
| Associated GPIs | |
| GCN Sequence Number | 062793 |
| GCN Sequence Number Description | ambrisentan TABLET 10 MG ORAL |
| HIC3 | B1B |
| HIC3 Description | PULMONARY ANTI-HTN, ENDOTHELIN RECEPTOR ANTAGONIST |
| GCN | 98567 |
| HICL Sequence Number | 034849 |
| HICL Sequence Number Description | AMBRISENTAN |
| Brand/Generic | Generic |
| Proprietary Name | Ambrisentan |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | AMBRISENTAN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | AMBRISENTAN |
| Labeler Name | Apotex Corp. |
| Pharmaceutical Class | Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210701 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 60505-4553-03 (60505455303)
| NDC Package Code | 60505-4553-3 |
|---|---|
| Billing NDC | 60505455303 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4553-3) |
| Marketing Start Date | 2022-09-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |