digoxin

Generic: digoxin

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

digoxin 125 ug/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-5921
Product ID 0904-5921_ff864791-a2ed-4fac-b687-3114f720f0ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077002
Listing Expiration 2026-12-31
Marketing Start 2009-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09045921
Hyphenated Format 0904-5921

Supplemental Identifiers

RxCUI
197604 197606
UNII
73K4184T59
NUI
N0000175568 M0003451

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 ANDA077002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 ug/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-5921-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-5921-61 100 BLISTER PACK in 1 CARTON (0904-5921-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

digoxin (125 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": "ff864791-a2ed-4fac-b687-3114f720f0ed", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["197604", "197606"], "spl_set_id": ["48cad559-c17b-4d41-a154-e664e958c1c0"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-5921-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-5921-61", "marketing_start_date": "20090610"}], "brand_name": "Digoxin", "product_id": "0904-5921_ff864791-a2ed-4fac-b687-3114f720f0ed", "dosage_form": "TABLET", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "0904-5921", "generic_name": "Digoxin", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": "125 ug/1"}], "application_number": "ANDA077002", "marketing_category": "ANDA", "marketing_start_date": "20090610", "listing_expiration_date": "20261231"}