digoxin

Generic: digoxin

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

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

digoxin .25 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6184
Product ID 0641-6184_8e188038-114a-4180-a9e4-e1ea6c9bdae2
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 06416184
Hyphenated Format 0641-6184

Supplemental Identifiers

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

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 25 AMPULE in 1 CARTON (0641-6184-25) / 2 mL in 1 AMPULE (0641-6184-01)
source: ndc

Packages (1)

0641-6184-25 25 AMPULE in 1 CARTON (0641-6184-25) / 2 mL in 1 AMPULE (0641-6184-01)

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": "8e188038-114a-4180-a9e4-e1ea6c9bdae2", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["104208"], "spl_set_id": ["9b9a4b3c-5f08-475a-a74d-0c7ebba40644"], "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": "25 AMPULE in 1 CARTON (0641-6184-25)  / 2 mL in 1 AMPULE (0641-6184-01)", "package_ndc": "0641-6184-25", "marketing_start_date": "19751024"}], "brand_name": "Digoxin", "product_id": "0641-6184_8e188038-114a-4180-a9e4-e1ea6c9bdae2", "dosage_form": "INJECTION", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "0641-6184", "generic_name": "Digoxin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "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"}