FDA.reportPublic FDA data

NDC 67046-1317-03 - Digoxin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67046-1317
Requested NDC
67046-1317-03
Package NDCs from labels
67046-1317-3, 67046-1317-03
Manufacturer
Coupler LLC
Effective date
2026-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Digoxin - Coupler LLCCoupler LLC2026-06-10HUMAN PRESCRIPTION DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DigoxinDIGOXINBryant Ranch Prepacke61d2108-d871-44c0-b12a-2e61fbb569672026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 197606
unii: 73K4184T59
DigoxinDIGOXINNCS HealthCare of KY, LLC dba Vangard Labs5886e233-b2da-4acb-be05-9bf40fb8e7f42026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 197604
unii: 73K4184T59
DIGOXINDIGOXINHF Acquisition Co LLC, DBA HealthFirst75c99fc4-33b6-c3ce-e053-2991aa0a4d882026-06-11Warnings, Adverse reactionsExact identifier
unii: 73K4184T59
DigoxinDIGOXINCoupler LLC53e5aec1-052b-454e-e063-6394a90a87f32026-06-10Warnings, Adverse reactionsExact identifier
application number: ANDA214982
ndc (package): 67046-1317-3
ndc (product): 67046-1317
ndc11 (package): 67046131703
rxcui: 197604
spl id: 53e5a4dc-8479-42f5-e063-6294a90a0c08
spl set id: 53e5aec1-052b-454e-e063-6394a90a87f3
unii: 73K4184T59
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
DigoxinDIGOXINCardinal Health 107, LLC6aba2b38-5de0-4813-9775-39d87613893d2026-04-22Warnings, Adverse reactionsExact identifier
unii: 73K4184T59
DigoxinDIGOXINHenry Schein, Inc.98d2ad5b-9ffa-4456-9a01-567636c3a4d22026-04-15Warnings, Adverse reactionsExact identifier
unii: 73K4184T59
DigoxinDIGOXINGolden State Medical Supply, Inc.2636527a-1ecd-455f-a928-19549ac83fa12026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 197606
rxcui: 197604
unii: 73K4184T59
DigoxinDIGOXINHikma Pharmaceuticals USA Inc.9b9a4b3c-5f08-475a-a74d-0c7ebba406442026-03-25Warnings, Adverse reactionsExact identifier
unii: 73K4184T59
DigoxinDIGOXINCardinal Health 107, LLC51925501-ab5b-4e12-a67e-ec2b4b592e832026-03-20Warnings, Adverse reactionsExact identifier
rxcui: 197604
unii: 73K4184T59
DigoxinDIGOXINREMEDYREPACK INC.dbc0bc24-f250-47e8-8d10-6aef551823d72026-03-18Warnings, Adverse reactionsExact identifier
application number: ANDA214982
rxcui: 197604
unii: 73K4184T59
DigoxinDIGOXINREMEDYREPACK INC.9ca08b66-55eb-4155-a8bd-6fa2282adab42026-03-18Warnings, Adverse reactionsExact identifier
application number: ANDA214982
rxcui: 197606
unii: 73K4184T59
DigoxinDIGOXINBryant Ranch Prepackdcf9b23b-5840-46ff-bb61-c57a02831a032026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 197606
unii: 73K4184T59
DigoxinDIGOXINBryant Ranch Prepacke23bf2a6-1c24-44c4-8135-e469900f84b22026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 197604
unii: 73K4184T59
DigoxinDIGOXINMajor Pharmaceuticals48cad559-c17b-4d41-a154-e664e958c1c02026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 197606
rxcui: 197604
unii: 73K4184T59
DigoxinDIGOXINA-S Medication Solutions9f5f6254-2b3a-46ce-9b55-e5826caeed912026-02-14Warnings, Adverse reactionsExact identifier
application number: ANDA214982
rxcui: 197604
unii: 73K4184T59
DigoxinDIGOXINA-S Medication Solutionsca595f0c-5bf0-4feb-8183-47832ee8c8202026-01-29Warnings, Adverse reactionsExact identifier
application number: ANDA214982
rxcui: 197606
unii: 73K4184T59
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
DigoxinDIGOXINOliva Therapeutics, LLC5b2d10d0-6e9d-4c39-a025-6b2f30ff62432026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 197606
rxcui: 197604
unii: 73K4184T59

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.