FDA.reportPublic FDA data

{12 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 9 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack

RxCUI
823777
RxNorm name
{12 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 9 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
Display name
{12 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 9 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
Full name
{12 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 9 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
Term type
GPCK
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

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
AranelleNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.0beef9d3-8326-48cf-b89a-fa794902c6c12023-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 823777

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
0beef9d3-8326-48cf-b89a-fa794902c6c1{12 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 9 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Noreth 0.035-0.5 MG (12) Oral Tablet / Eth estra-Noreth 0.035-1 MG (9) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack [PSN]211Aranelle ® (norethindrone and ethinyl estradiol tablets, USP)20230131