digoxin

Generic: digoxin

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler propharma distribution
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

digoxin .25 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-410
Product ID 84549-410_45b0d1e0-d1f5-28f6-e063-6394a90aaa51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083391
Listing Expiration 2026-12-31
Marketing Start 1975-10-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549410
Hyphenated Format 84549-410

Supplemental Identifiers

RxCUI
104208
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 ANDA083391 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 2 mL in 1 AMPULE (84549-410-35)
source: ndc

Packages (1)

84549-410-35 2 mL in 1 AMPULE (84549-410-35)

Ingredients (1)

digoxin (.25 mg/mL)

Linked Drug Pages (1)

Digoxin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "45b0d1e0-d1f5-28f6-e063-6394a90aaa51", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["104208"], "spl_set_id": ["45b0d1e0-d1f6-28f6-e063-6394a90aaa51"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 AMPULE (84549-410-35)", "package_ndc": "84549-410-35", "marketing_start_date": "20251211"}], "brand_name": "Digoxin", "product_id": "84549-410_45b0d1e0-d1f5-28f6-e063-6394a90aaa51", "dosage_form": "INJECTION", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "84549-410", "generic_name": "Digoxin", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": ".25 mg/mL"}], "application_number": "ANDA083391", "marketing_category": "ANDA", "marketing_start_date": "19751024", "listing_expiration_date": "20261231"}