FDA.reportPublic FDA data

drospiren-estetrol 3-14.2 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack

RxCUI
2539036
RxNorm name
drospiren-estetrol 3-14.2 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack
Display name
drospiren-estetrol 3-14.2 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack
Full name
drospiren-estetrol 3-14.2 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

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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
NextstellisDROSPIRENONE AND ESTETROLMayne Pharmac5270073-d083-4109-ae4b-156986175e0a2023-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2539036

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
c5270073-d083-4109-ae4b-156986175e0a{24 (drospirenone 3 MG / estetrol 14.2 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · drospiren-estetrol 3-14.2 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack [PSN]27These highlights do not include all the information needed to use NEXTSTELLIS safely and effectively. See full prescribing information for NEXTSTELLIS. NEXTSTELLIS ® (drospirenone and estetrol tablets), for oral use Initial U.S. Approval: 202120230511