FDA.reportPublic FDA data

{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day]

RxCUI
753483
RxNorm name
{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day]
Display name
{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day]
Full name
{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day]
Term type
BPCK
Status
DailyMed mapping
Updated
2026-06-04 23:39:09

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kelnor 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLA-S Medication Solutionscfa297a6-1cc7-4751-b8ea-0e57965f1ca92023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 753483
Kelnor 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.96a73786-22b1-457e-be73-80b699996d402022-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 753483

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
96a73786-22b1-457e-be73-80b699996d40{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day] [BPCK] · Kelnor 1/35 28 Day Pack [PSN] · Kelnor 1/35 28 Day Pack [SY]314Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP)20221019
cfa297a6-1cc7-4751-b8ea-0e57965f1ca9{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day] [BPCK] · Kelnor 1/35 28 Day Pack [PSN] · Kelnor 1/35 28 Day Pack [SY]312Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP)20230204
994cefc2-0724-4b56-a816-ccdabef5492e{21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day] [BPCK] · Kelnor 1/35 28 Day Pack [PSN] · Kelnor 1/35 28 Day Pack [SY]32Kelnor™ 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets, USP)20110124