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NDC 76385-0111-01 Carvedilol 6.25 mg/1 Details
Carvedilol 6.25 mg/1
Carvedilol is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bayshore Pharmaceuticals LLC. The primary component is CARVEDILOL.
MedlinePlus Drug Summary
Carvedilol is used to treat heart failure (condition in which the heart cannot pump enough blood to all parts of the body) and high blood pressure. It also is used to treat people who have had a heart attack. Carvedilol is often used in combination with other medications. Carvedilol is in a class of medications called beta-blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Related Packages: 76385-0111-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Carvedilol
Product Information
| NDC | 76385-0111 |
|---|---|
| Product ID | 76385-111_169edf1c-826c-4153-a26f-155cad96b3ea |
| Associated GPIs | 33300007000310 |
| GCN Sequence Number | 028109 |
| GCN Sequence Number Description | carvedilol TABLET 6.25 MG ORAL |
| HIC3 | J7A |
| HIC3 Description | ALPHA/BETA-ADRENERGIC BLOCKING AGENTS |
| GCN | 01554 |
| HICL Sequence Number | 013795 |
| HICL Sequence Number Description | CARVEDILOL |
| Brand/Generic | Generic |
| Proprietary Name | Carvedilol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Carvedilol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 6.25 |
| Active Ingredient Units | mg/1 |
| Substance Name | CARVEDILOL |
| Labeler Name | Bayshore Pharmaceuticals LLC |
| Pharmaceutical Class | Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078384 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 76385-0111-01 (76385011101)
| NDC Package Code | 76385-111-01 |
|---|---|
| Billing NDC | 76385011101 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-111-01) |
| Marketing Start Date | 2016-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |