flecainide acetate

Generic: flecainide acetate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7316
Product ID 50090-7316_c8e8b229-cc66-4cdf-a320-531ec28560e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215599
Listing Expiration 2026-12-31
Marketing Start 2022-09-15

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907316
Hyphenated Format 50090-7316

Supplemental Identifiers

RxCUI
886666
UNII
M8U465Q1WQ

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name flecainide acetate (source: ndc)
Generic Name flecainide acetate (source: ndc)
Application Number ANDA215599 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (50090-7316-0)
source: ndc

Packages (1)

50090-7316-0 60 TABLET in 1 BOTTLE (50090-7316-0)

Ingredients (1)

flecainide acetate (100 mg/1)

Linked Drug Pages (1)

Flecainide Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c8e8b229-cc66-4cdf-a320-531ec28560e1", "openfda": {"unii": ["M8U465Q1WQ"], "rxcui": ["886666"], "spl_set_id": ["9aa3bd74-d8c3-4e40-a1be-19111492b652"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-7316-0)", "package_ndc": "50090-7316-0", "marketing_start_date": "20241014"}], "brand_name": "Flecainide Acetate", "product_id": "50090-7316_c8e8b229-cc66-4cdf-a320-531ec28560e1", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "50090-7316", "generic_name": "flecainide acetate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "100 mg/1"}], "application_number": "ANDA215599", "marketing_category": "ANDA", "marketing_start_date": "20220915", "listing_expiration_date": "20261231"}