FDA.reportPublic FDA data

Setlakin 91 Day Pack

RxCUI
1661092
RxNorm name
Setlakin 91 Day Pack
Display name
Setlakin 91 Day Pack
Full name
Setlakin 91 Day Pack
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

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
SETLAKINLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCb7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1661092

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
b7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb{84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Setlakin 91 Day] [BPCK] · Setlakin 91 Day Pack [PSN] · Setlakin 91 Day Pack [SY]39These highlights do not include all the information needed to use SETLAKIN safely and effectively. See full prescribing information for SETLAKIN. SETLAKIN (levonorgestrel and ethinyl estradiol tablets) for oral use Initial U.S. Approval:198220251205