FDA.reportPublic FDA data

ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Chewable Tablet

RxCUI
2539224
RxNorm name
ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Chewable Tablet
Display name
ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Chewable Tablet
Full name
ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Chewable Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TyblumeLEVONORGESTREL AND ETHINYL ESTRADIOLExeltis USA, Inc.b2482d51-d606-4aaa-8af4-19e4fe2f88722026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2539224

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b2482d51-d606-4aaa-8af4-19e4fe2f8872ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Chewable Tablet [PSN] · ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Chewable Tablet [SCD]26These highlights do not include all the information needed to use TYBLUME safely and effectively. See full prescribing information for TYBLUME. TYBLUME (levonorgestrel and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1968 (norgestrel and ethinyl estradiol)20230212