FDA.reportPublic FDA data

Galbriela 28 Day Pack

RxCUI
2704559
RxNorm name
Galbriela 28 Day Pack
Display name
Galbriela 28 Day Pack
Full name
Galbriela 28 Day Pack
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

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
GALBRIELANORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXiromed, LLC47465e7e-64f2-690b-166e-0e1c3e5bec7a2024-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2704559

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
47465e7e-64f2-690b-166e-0e1c3e5bec7a{24 (ethinyl estradiol 0.025 MG / norethindrone 0.8 MG Chewable Tablet) / 4 (ferrous fumarate 75 MG Chewable Tablet) } Pack [Galbriela 28 Day] [BPCK] · Galbriela 28 Day Pack [PSN] · Galbriela 28 Day Pack [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