digoxin

Generic: digoxin

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

digoxin .25 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-748
Product ID 10135-748_40a9ac35-555b-4751-e063-6394a90a98aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215307
Listing Expiration 2026-12-31
Marketing Start 2022-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135748
Hyphenated Format 10135-748

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 ANDA215307 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-748-01)
  • 1000 TABLET in 1 BOTTLE (10135-748-10)
source: ndc

Packages (2)

10135-748-01 100 TABLET in 1 BOTTLE (10135-748-01) 10135-748-10 1000 TABLET in 1 BOTTLE (10135-748-10)

Ingredients (1)

digoxin (.25 mg/1)

Linked Drug Pages (1)

Digoxin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40a9ac35-555b-4751-e063-6394a90a98aa", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["197604", "197606"], "spl_set_id": ["e104c3c5-e4b8-7dbd-e053-2995a90ae339"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-748-01)", "package_ndc": "10135-748-01", "marketing_start_date": "20220601"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (10135-748-10)", "package_ndc": "10135-748-10", "marketing_start_date": "20220601"}], "brand_name": "Digoxin", "product_id": "10135-748_40a9ac35-555b-4751-e063-6394a90a98aa", "dosage_form": "TABLET", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "10135-748", "generic_name": "Digoxin", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": ".25 mg/1"}], "application_number": "ANDA215307", "marketing_category": "ANDA", "marketing_start_date": "20220601", "listing_expiration_date": "20261231"}