lanoxin

Generic: digoxin

Labeler: covis pharma us, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lanoxin
Generic Name digoxin
Labeler covis pharma us, inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

digoxin 250 ug/mL

Manufacturer
Covis Pharma US, Inc

Identifiers & Regulatory

Product NDC 70515-261
Product ID 70515-261_415f97e2-9ce0-b282-e063-6394a90ab0a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA009330
Listing Expiration 2026-12-31
Marketing Start 2019-10-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70515261
Hyphenated Format 70515-261

Supplemental Identifiers

RxCUI
104208 204504 208135 208137
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 lanoxin (source: ndc)
Generic Name digoxin (source: ndc)
Application Number NDA009330 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (70515-261-10) / 2 mL in 1 VIAL
source: ndc

Packages (1)

70515-261-10 10 VIAL in 1 BOX (70515-261-10) / 2 mL in 1 VIAL

Ingredients (1)

digoxin (250 ug/mL)

Linked Drug Pages (1)

LANOXIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "415f97e2-9ce0-b282-e063-6394a90ab0a8", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["104208", "204504", "208135", "208137"], "spl_set_id": ["9ec84cac-6ecc-43dc-8006-6ccc029e2707"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Covis Pharma US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (70515-261-10)  / 2 mL in 1 VIAL", "package_ndc": "70515-261-10", "marketing_start_date": "20191029"}], "brand_name": "LANOXIN", "product_id": "70515-261_415f97e2-9ce0-b282-e063-6394a90ab0a8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "70515-261", "generic_name": "digoxin", "labeler_name": "Covis Pharma US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LANOXIN", "active_ingredients": [{"name": "DIGOXIN", "strength": "250 ug/mL"}], "application_number": "NDA009330", "marketing_category": "NDA", "marketing_start_date": "20191029", "listing_expiration_date": "20261231"}