Search by Drug Name or NDC
NDC 76385-0146-01 Flecainide Acetate 100 mg/1 Details
Flecainide Acetate 100 mg/1
Flecainide Acetate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bayshore Pharmaceuticals LLC. The primary component is FLECAINIDE ACETATE.
MedlinePlus Drug Summary
Flecainide is used to prevent certain types of life-threatening irregular heartbeats. Flecainide is in a class of medications called antiarrhythmics. It works by slowing electrical signals in the heart to stabilize the heart rhythm.
Related Packages: 76385-0146-01Last Updated: 05/26/2024
MedLinePlus Full Drug Details: Flecainide
Product Information
| NDC | 76385-0146 |
|---|---|
| Product ID | 76385-146_d6378aa3-785e-4c2b-867b-db0fa23f3d15 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Flecainide Acetate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | flecainide acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | FLECAINIDE ACETATE |
| Labeler Name | Bayshore Pharmaceuticals LLC |
| Pharmaceutical Class | Antiarrhythmic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210683 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 76385-0146-01 (76385014601)
| NDC Package Code | 76385-146-01 |
|---|---|
| Billing NDC | 76385014601 |
| Package | 100 TABLET in 1 BOTTLE (76385-146-01) |
| Marketing Start Date | 2024-01-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |