digoxin

Generic: digoxin

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

digoxin 250 ug/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-9822
Product ID 0115-9822_606fde89-1d1f-43b4-a06b-aaa36b994315
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078556
Listing Expiration 2026-12-31
Marketing Start 2009-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01159822
Hyphenated Format 0115-9822

Supplemental Identifiers

RxCUI
197604 197606
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 ANDA078556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 ug/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0115-9822-01)
  • 500 TABLET in 1 BOTTLE (0115-9822-02)
  • 1000 TABLET in 1 BOTTLE (0115-9822-03)
source: ndc

Packages (3)

0115-9822-01 100 TABLET in 1 BOTTLE (0115-9822-01) 0115-9822-02 500 TABLET in 1 BOTTLE (0115-9822-02) 0115-9822-03 1000 TABLET in 1 BOTTLE (0115-9822-03)

Ingredients (1)

digoxin (250 ug/1)

Linked Drug Pages (1)

Digoxin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "606fde89-1d1f-43b4-a06b-aaa36b994315", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["197604", "197606"], "spl_set_id": ["dfac7f13-28be-423d-9389-9089da29da17"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0115-9822-01)", "package_ndc": "0115-9822-01", "marketing_start_date": "20090720"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0115-9822-02)", "package_ndc": "0115-9822-02", "marketing_start_date": "20090720"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0115-9822-03)", "package_ndc": "0115-9822-03", "marketing_start_date": "20090720"}], "brand_name": "Digoxin", "product_id": "0115-9822_606fde89-1d1f-43b4-a06b-aaa36b994315", "dosage_form": "TABLET", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "0115-9822", "generic_name": "DIGOXIN", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": "250 ug/1"}], "application_number": "ANDA078556", "marketing_category": "ANDA", "marketing_start_date": "20090720", "listing_expiration_date": "20261231"}