FDA.reportPublic FDA data

ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet

RxCUI
1099638
RxNorm name
ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet
Display name
ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet
Full name
ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
Kaitlib FeNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.4826031b-c2b7-4cd0-a4da-59068bd344302025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099638
GALBRIELANORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXiromed, LLC47465e7e-64f2-690b-166e-0e1c3e5bec7a2024-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099638

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4826031b-c2b7-4cd0-a4da-59068bd34430ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet [PSN] · ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet [SCD] · ethinyl estradiol 25 MCG / norethindrone 0.8 MG Chewable Tablet [SY]314These highlights do not include all the information needed to use KAITLIB TM FE safely and effectively. See full prescribing information for KAITLIB FE. KAITLIB Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets), for oral use Initial U.S. Approval: 197420251202
47465e7e-64f2-690b-166e-0e1c3e5bec7aethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet [PSN] · ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet [SCD] · ethinyl estradiol 25 MCG / norethindrone 0.8 MG Chewable Tablet [SY]34These highlights do not include all the information needed to use GALBRIELA safely and effectively. See full prescribing information for GALBRIELA . GALBRIELA TM (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets), for oral use Initial U.S. Approval: 197420240831