digoxin

Generic: digoxin

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

digoxin 250 ug/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1992
Product ID 69238-1992_e9480117-8eb3-41e7-8928-1573d3d21d0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076268
Listing Expiration 2026-12-31
Marketing Start 2019-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381992
Hyphenated Format 69238-1992

Supplemental Identifiers

RxCUI
197604 197606
UPC
0369238199215 0369238199116
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 ANDA076268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69238-1992-1)
  • 1000 TABLET in 1 BOTTLE (69238-1992-7)
source: ndc

Packages (2)

69238-1992-1 100 TABLET in 1 BOTTLE (69238-1992-1) 69238-1992-7 1000 TABLET in 1 BOTTLE (69238-1992-7)

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": "e9480117-8eb3-41e7-8928-1573d3d21d0e", "openfda": {"nui": ["N0000175568", "M0003451"], "upc": ["0369238199215", "0369238199116"], "unii": ["73K4184T59"], "rxcui": ["197604", "197606"], "spl_set_id": ["f3d29508-e7cc-47ff-845d-b5375ee30407"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69238-1992-1)", "package_ndc": "69238-1992-1", "marketing_start_date": "20190401"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69238-1992-7)", "package_ndc": "69238-1992-7", "marketing_start_date": "20190401"}], "brand_name": "Digoxin", "product_id": "69238-1992_e9480117-8eb3-41e7-8928-1573d3d21d0e", "dosage_form": "TABLET", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "69238-1992", "generic_name": "Digoxin", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": "250 ug/1"}], "application_number": "ANDA076268", "marketing_category": "ANDA", "marketing_start_date": "20190401", "listing_expiration_date": "20261231"}