digoxin

Generic: digoxin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

digoxin 250 ug/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-441
Product ID 57664-441_47e1a46c-562d-ac4c-e063-6294a90a9b81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076363
Listing Expiration 2027-12-31
Marketing Start 2015-02-17

Pharmacologic Class

Established (EPC)
cardiac glycoside [epc]
Chemical Structure
cardiac glycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664441
Hyphenated Format 57664-441

Supplemental Identifiers

RxCUI
197604 197606
UNII
73K4184T59
NUI
N0000175568 M0003451

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 digoxin (source: ndc)
Generic Name digoxin (source: ndc)
Application Number ANDA076363 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (57664-441-18)
  • 100 TABLET in 1 BOTTLE (57664-441-88)
source: ndc

Packages (2)

57664-441-18 1000 TABLET in 1 BOTTLE (57664-441-18) 57664-441-88 100 TABLET in 1 BOTTLE (57664-441-88)

Ingredients (1)

digoxin (250 ug/1)

Linked Drug Pages (1)

Digoxin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e1a46c-562d-ac4c-e063-6294a90a9b81", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["197604", "197606"], "spl_set_id": ["62795623-a2bc-4dd2-8989-3b9782bfd80e"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (57664-441-18)", "package_ndc": "57664-441-18", "marketing_start_date": "20150217"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (57664-441-88)", "package_ndc": "57664-441-88", "marketing_start_date": "20150217"}], "brand_name": "Digoxin", "product_id": "57664-441_47e1a46c-562d-ac4c-e063-6294a90a9b81", "dosage_form": "TABLET", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "57664-441", "generic_name": "Digoxin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": "250 ug/1"}], "application_number": "ANDA076363", "marketing_category": "ANDA", "marketing_start_date": "20150217", "listing_expiration_date": "20271231"}