flecainide acetate

Generic: flecainide acetate

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 50 mg/1

Manufacturer
UNICHEM PHARMACEUTICALS (USA), INC.

Identifiers & Regulatory

Product NDC 76385-145
Product ID 76385-145_6e5f6cbe-c7eb-4168-b02b-119798e895d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210683
Listing Expiration 2027-12-31
Marketing Start 2024-01-11

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76385145
Hyphenated Format 76385-145

Supplemental Identifiers

RxCUI
886662 886666 886671
UNII
M8U465Q1WQ

Packaging Origin

Original Packager
true

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 ANDA210683 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76385-145-01)
  • 60 TABLET in 1 BOTTLE (76385-145-60)
source: ndc

Packages (2)

76385-145-01 100 TABLET in 1 BOTTLE (76385-145-01) 76385-145-60 60 TABLET in 1 BOTTLE (76385-145-60)

Ingredients (1)

flecainide acetate (50 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": "6e5f6cbe-c7eb-4168-b02b-119798e895d6", "openfda": {"unii": ["M8U465Q1WQ"], "rxcui": ["886662", "886666", "886671"], "spl_set_id": ["5b33e96a-8336-46c4-aac7-4a6c0039cc80"], "manufacturer_name": ["UNICHEM PHARMACEUTICALS (USA), INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76385-145-01)", "package_ndc": "76385-145-01", "marketing_start_date": "20240111"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76385-145-60)", "package_ndc": "76385-145-60", "marketing_start_date": "20240111"}], "brand_name": "Flecainide Acetate", "product_id": "76385-145_6e5f6cbe-c7eb-4168-b02b-119798e895d6", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "76385-145", "generic_name": "flecainide acetate", "labeler_name": "UNICHEM PHARMACEUTICALS (USA), INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "50 mg/1"}], "application_number": "ANDA210683", "marketing_category": "ANDA", "marketing_start_date": "20240111", "listing_expiration_date": "20271231"}