digoxin

Generic: digoxin

Labeler: amici pharma, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler amici pharma, inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

digoxin .05 mg/mL

Manufacturer
Amici Pharma, Inc

Identifiers & Regulatory

Product NDC 69292-605
Product ID 69292-605_6ea84176-ac4e-47c6-b65c-c203e6e8de98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215209
Listing Expiration 2026-12-31
Marketing Start 2022-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69292605
Hyphenated Format 69292-605

Supplemental Identifiers

RxCUI
393245
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 ANDA215209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69292-605-60) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

69292-605-60 1 BOTTLE in 1 CARTON (69292-605-60) / 60 mL in 1 BOTTLE

Ingredients (1)

digoxin (.05 mg/mL)

Linked Drug Pages (1)

Digoxin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6ea84176-ac4e-47c6-b65c-c203e6e8de98", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["393245"], "spl_set_id": ["eda7193a-e139-41d5-a11b-dc6241645995"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Amici Pharma, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69292-605-60)  / 60 mL in 1 BOTTLE", "package_ndc": "69292-605-60", "marketing_start_date": "20220610"}], "brand_name": "Digoxin", "product_id": "69292-605_6ea84176-ac4e-47c6-b65c-c203e6e8de98", "dosage_form": "SOLUTION", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "69292-605", "generic_name": "Digoxin", "labeler_name": "Amici Pharma, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": ".05 mg/mL"}], "application_number": "ANDA215209", "marketing_category": "ANDA", "marketing_start_date": "20220610", "listing_expiration_date": "20261231"}