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NDC 76385-0145-01 Flecainide Acetate 50 mg/1 Details
Flecainide Acetate 50 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.
Product Information
| NDC | 76385-0145 |
|---|---|
| Product ID | 76385-145_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 | 50 |
| 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 76385-0145-01 (76385014501)
| NDC Package Code | 76385-145-01 |
|---|---|
| Billing NDC | 76385014501 |
| Package | 100 TABLET in 1 BOTTLE (76385-145-01) |
| Marketing Start Date | 2024-01-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |