digoxin

Generic: digoxin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

digoxin .0625 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-436
Product ID 59651-436_1338ce78-5a23-4dd2-bb1b-335f35cb2646
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214982
Listing Expiration 2026-12-31
Marketing Start 2022-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651436
Hyphenated Format 59651-436

Supplemental Identifiers

RxCUI
197604 197606 245273
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 ANDA214982 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .0625 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-436-01)
  • 1000 TABLET in 1 BOTTLE (59651-436-99)
source: ndc

Packages (2)

Ingredients (1)

digoxin (.0625 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1338ce78-5a23-4dd2-bb1b-335f35cb2646", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["197604", "197606", "245273"], "spl_set_id": ["2bcd56ee-4497-4b8d-84db-a1470c77827b"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-436-01)", "package_ndc": "59651-436-01", "marketing_start_date": "20220208"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (59651-436-99)", "package_ndc": "59651-436-99", "marketing_start_date": "20220208"}], "brand_name": "Digoxin", "product_id": "59651-436_1338ce78-5a23-4dd2-bb1b-335f35cb2646", "dosage_form": "TABLET", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "59651-436", "generic_name": "Digoxin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": ".0625 mg/1"}], "application_number": "ANDA214982", "marketing_category": "ANDA", "marketing_start_date": "20220208", "listing_expiration_date": "20261231"}