digoxin

Generic: digoxin

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

Drug Facts

Product Profile

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

digoxin .125 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-201
Product ID 70954-201_ee465d1a-f5ee-477b-b20e-3ce8705e7472
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215307
Listing Expiration 2026-12-31
Marketing Start 2021-11-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954201
Hyphenated Format 70954-201

Supplemental Identifiers

RxCUI
197604 197606 245273
UPC
0370954201106 0370954201205 0370954202103 0370954200109
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 ANDA215307 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .125 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-201-10)
  • 1000 TABLET in 1 BOTTLE (70954-201-20)
source: ndc

Packages (2)

70954-201-10 100 TABLET in 1 BOTTLE (70954-201-10) 70954-201-20 1000 TABLET in 1 BOTTLE (70954-201-20)

Ingredients (1)

digoxin (.125 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": "ee465d1a-f5ee-477b-b20e-3ce8705e7472", "openfda": {"nui": ["N0000175568", "M0003451"], "upc": ["0370954201106", "0370954201205", "0370954202103", "0370954200109"], "unii": ["73K4184T59"], "rxcui": ["197604", "197606", "245273"], "spl_set_id": ["dba3b3f7-3ff2-4996-8653-b0e54a398bf9"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-201-10)", "package_ndc": "70954-201-10", "marketing_start_date": "20211122"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (70954-201-20)", "package_ndc": "70954-201-20", "marketing_start_date": "20211122"}], "brand_name": "Digoxin", "product_id": "70954-201_ee465d1a-f5ee-477b-b20e-3ce8705e7472", "dosage_form": "TABLET", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "70954-201", "generic_name": "Digoxin", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": ".125 mg/1"}], "application_number": "ANDA215307", "marketing_category": "ANDA", "marketing_start_date": "20211122", "listing_expiration_date": "20261231"}