digoxin

Generic: digoxin

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

digoxin .25 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9850
Product ID 0404-9850_8ac9d178-0b00-41d2-b564-084f75a50eac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083391
Listing Expiration 2026-12-31
Marketing Start 2022-01-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049850
Hyphenated Format 0404-9850

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
  • 1 AMPULE in 1 BAG (0404-9850-02) / 2 mL in 1 AMPULE
source: ndc

Packages (1)

0404-9850-02 1 AMPULE in 1 BAG (0404-9850-02) / 2 mL in 1 AMPULE

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": "8ac9d178-0b00-41d2-b564-084f75a50eac", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["104208"], "spl_set_id": ["98d2ad5b-9ffa-4456-9a01-567636c3a4d2"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 AMPULE in 1 BAG (0404-9850-02)  / 2 mL in 1 AMPULE", "package_ndc": "0404-9850-02", "marketing_start_date": "20220110"}], "brand_name": "Digoxin", "product_id": "0404-9850_8ac9d178-0b00-41d2-b564-084f75a50eac", "dosage_form": "INJECTION", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "0404-9850", "generic_name": "Digoxin", "labeler_name": "Henry Schein, 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": "20220110", "listing_expiration_date": "20261231"}