FDA.reportPublic FDA data

Simpesse 91 Day Pack

RxCUI
1918056
RxNorm name
Simpesse 91 Day Pack
Display name
Simpesse 91 Day Pack
Full name
Simpesse 91 Day Pack
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimpesseLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLAurobindo Pharma Limitedabea62b3-6a55-40a4-9e68-1ee9801e0f2c2025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1918056

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
abea62b3-6a55-40a4-9e68-1ee9801e0f2c{7 (ethinyl estradiol 0.01 MG Oral Tablet) / 84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) } Pack [Simpesse 91 Day] [BPCK] · Simpesse 91 Day Pack [PSN] · Simpesse 91 Day Pack [SY]312These highlights do not include all the information needed to use SIMPESSE safely and effectively. See full prescribing information for SIMPESSE. SIMPESSE ® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 198220250801