FDA.reportPublic FDA data

ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet

RxCUI
1359130
RxNorm name
ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet
Display name
ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet
Full name
ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tilia FeNDAC AND EE TABLETS AND FERROUS FUMARATE TABLETSMayne Pharma Inc.cebfb589-1b34-4f51-a0c8-c2c0cf4c71452025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359130
XARAH FENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE TABLETSXiromed LLC2c5cf9c3-948e-964b-7424-21c84461df932025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359130
Tilia FeNDAC AND EE TABLETS AND FERROUS FUMARATE TABLETSDr. Reddys Laboratories Inc.118fb017-b44d-4223-ac5a-501ca96de2102024-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359130
Tri-Legest Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.6f9d30d9-5553-4cbd-a099-ff045bc858212023-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359130
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEMylan Pharmaceuticals Inc.054917fa-573b-4b16-a719-ece6c09096562021-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359130

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 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6f9d30d9-5553-4cbd-a099-ff045bc85821norethindrone acetate 1 MG / ethinyl estradiol 30 MCG Oral Tablet [PSN] · ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet [SCD] · ethinyl estradiol 30 MCG / norethindrone acetate 1 MG Oral Tablet [SY]312Tri-Legest ® Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay.20230321
054917fa-573b-4b16-a719-ece6c0909656norethindrone acetate 1 MG / ethinyl estradiol 30 MCG Oral Tablet [PSN] · ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet [SCD] · ethinyl estradiol 30 MCG / norethindrone acetate 1 MG Oral Tablet [SY]34Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets* *Ferrous fumarate tablets are not USP for dissolution and assay.20211129
cebfb589-1b34-4f51-a0c8-c2c0cf4c7145norethindrone acetate 1 MG / ethinyl estradiol 30 MCG Oral Tablet [PSN] · ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet [SCD] · ethinyl estradiol 30 MCG / norethindrone acetate 1 MG Oral Tablet [SY]33Tilia® Fe(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) 1 mg/0.02 mg, 1 mg/0.03 mg, 1 mg/0.035 mg *Ferrous fumarate tablets are not USP for dissolution.20250908
2c5cf9c3-948e-964b-7424-21c84461df93norethindrone acetate 1 MG / ethinyl estradiol 30 MCG Oral Tablet [PSN] · ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet [SCD] · ethinyl estradiol 30 MCG / norethindrone acetate 1 MG Oral Tablet [SY]32Xarah Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay.20250205
118fb017-b44d-4223-ac5a-501ca96de210norethindrone acetate 1 MG / ethinyl estradiol 30 MCG Oral Tablet [PSN] · ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet [SCD] · ethinyl estradiol 30 MCG / norethindrone acetate 1 MG Oral Tablet [SY]32Tilia ® Fe(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*)*Ferrous fumarate tablets are not USP for dissolution.20240601
3cb9494c-4d70-4ebd-98ec-0e28021c1feenorethindrone acetate 1 MG / ethinyl estradiol 30 MCG Oral Tablet [PSN] · ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet [SCD] · ethinyl estradiol 30 MCG / norethindrone acetate 1 MG Oral Tablet [SY]31Tilia™ Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay.20110729
01765e76-e656-4539-8112-8b7709597c79norethindrone acetate 1 MG / ethinyl estradiol 30 MCG Oral Tablet [PSN] · ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet [SCD] · ethinyl estradiol 30 MCG / norethindrone acetate 1 MG Oral Tablet [SY]31Tilia™ Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay.20101207