FDA.reportPublic FDA data

{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Activella 0.5/0.1 28 Day]

RxCUI
1359125
RxNorm name
{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Activella 0.5/0.1 28 Day]
Display name
{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Activella 0.5/0.1 28 Day]
Full name
{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Activella 0.5/0.1 28 Day]
Term type
BPCK
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

RxNav Current And Historical NDCs#

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UNII Substances#

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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
ActivellaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals LLCd4b0c1dd-aae9-4ca2-958c-71dbe5d0fab02023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359125

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
d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0{28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Activella 0.5/0.1 28 Day] [BPCK] · Activella 0.5/0.1 28 Day Pack [PSN] · Activella 0.5/0.1 28 Day Pack [SY]318These highlights do not include all the information needed to use ACTIVELLA safely and effectively. See full prescribing information for ACTIVELLA. ACTIVELLA ® (estradiol/norethindrone acetate) tablets, for oral use Initial U.S. Approval: 199820231130