digoxin

Generic: digoxin

Labeler: oliva therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name digoxin
Generic Name digoxin
Labeler oliva therapeutics, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

digoxin 125 ug/1

Manufacturer
Oliva Therapeutics, LLC

Identifiers & Regulatory

Product NDC 82685-201
Product ID 82685-201_48481a34-0b24-a796-e063-6294a90af307
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076268
Listing Expiration 2027-12-31
Marketing Start 2022-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82685201
Hyphenated Format 82685-201

Supplemental Identifiers

RxCUI
197604 197606
UPC
0382685202017 0382685201010
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 ANDA076268 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 ug/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (82685-201-01)
  • 1000 TABLET in 1 BOTTLE (82685-201-10)
source: ndc

Packages (2)

82685-201-01 100 TABLET in 1 BOTTLE (82685-201-01) 82685-201-10 1000 TABLET in 1 BOTTLE (82685-201-10)

Ingredients (1)

digoxin (125 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": "48481a34-0b24-a796-e063-6294a90af307", "openfda": {"nui": ["N0000175568", "M0003451"], "upc": ["0382685202017", "0382685201010"], "unii": ["73K4184T59"], "rxcui": ["197604", "197606"], "spl_set_id": ["5b2d10d0-6e9d-4c39-a025-6b2f30ff6243"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Oliva Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82685-201-01)", "package_ndc": "82685-201-01", "marketing_start_date": "20220901"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (82685-201-10)", "package_ndc": "82685-201-10", "marketing_start_date": "20220901"}], "brand_name": "Digoxin", "product_id": "82685-201_48481a34-0b24-a796-e063-6294a90af307", "dosage_form": "TABLET", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "82685-201", "generic_name": "Digoxin", "labeler_name": "Oliva Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Digoxin", "active_ingredients": [{"name": "DIGOXIN", "strength": "125 ug/1"}], "application_number": "ANDA076268", "marketing_category": "ANDA", "marketing_start_date": "20220901", "listing_expiration_date": "20271231"}