flecainide acetate

Generic: flecainide acetate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-321
Product ID 50268-321_48253893-9512-565b-e063-6294a90a8ad8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075442
Listing Expiration 2027-12-31
Marketing Start 2015-02-12

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268321
Hyphenated Format 50268-321

Supplemental Identifiers

RxCUI
886662 886666 886671
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 ANDA075442 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-321-15) / 1 TABLET in 1 BLISTER PACK (50268-321-11)
source: ndc

Packages (1)

50268-321-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-321-15) / 1 TABLET in 1 BLISTER PACK (50268-321-11)

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": "48253893-9512-565b-e063-6294a90a8ad8", "openfda": {"unii": ["M8U465Q1WQ"], "rxcui": ["886662", "886666", "886671"], "spl_set_id": ["f53e1a49-6185-6db4-c867-ffd1241a8cb7"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-321-15)  / 1 TABLET in 1 BLISTER PACK (50268-321-11)", "package_ndc": "50268-321-15", "marketing_start_date": "20150212"}], "brand_name": "Flecainide Acetate", "product_id": "50268-321_48253893-9512-565b-e063-6294a90a8ad8", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "50268-321", "generic_name": "Flecainide Acetate", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "100 mg/1"}], "application_number": "ANDA075442", "marketing_category": "ANDA", "marketing_start_date": "20150212", "listing_expiration_date": "20271231"}