digoxin

Generic: digoxin

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

digoxin .05 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0057
Product ID 0054-0057_db501397-8e41-4498-8626-49c6bfd79971
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021648
Listing Expiration 2026-12-31
Marketing Start 2004-08-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540057
Hyphenated Format 0054-0057

Supplemental Identifiers

RxCUI
393245
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 NDA021648 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 60 mL in 1 BOTTLE (0054-0057-46)
source: ndc

Packages (1)

0054-0057-46 60 mL in 1 BOTTLE (0054-0057-46)

Ingredients (1)

digoxin (.05 mg/mL)

Linked Drug Pages (1)

Digoxin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "db501397-8e41-4498-8626-49c6bfd79971", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["393245"], "spl_set_id": ["1b7e5c6e-e052-41b0-a4ce-05dfe62faaaf"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE (0054-0057-46)", "package_ndc": "0054-0057-46", "marketing_start_date": "20040826"}], "brand_name": "Digoxin", "product_id": "0054-0057_db501397-8e41-4498-8626-49c6bfd79971", "dosage_form": "SOLUTION", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "0054-0057", "generic_name": "Digoxin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": ".05 mg/mL"}], "application_number": "NDA021648", "marketing_category": "NDA", "marketing_start_date": "20040826", "listing_expiration_date": "20261231"}