FDA.reportPublic FDA data

norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral Tablet

RxCUI
238015
RxNorm name
norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral Tablet
Display name
norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral Tablet
Full name
norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRIELLYNNORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAc0e2c5b4-70ac-4b41-aa71-00e506dbb72f2026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 238015
PhilithNORETHINDRONE AND ETHINYL ESTRADIOL TABLETSNorthstar Rx LLC77b8d3ef-f3ac-4148-84f0-f6cb327c9f782025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 238015
VyfemlaNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.175ce5c4-d332-4c97-a0b8-10821dc813ef2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238015
RhuzdahNORETHINDRONE AND ETHINYL ESTRADIOL TABLETAurobindo Pharma Limiteddea10e78-0e7b-4404-9c3a-ed2447a1788b2023-11-23Warnings, Adverse reactionsExact identifier
rxcui: 238015
BalzivaNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.36a282d2-7285-442b-9574-dfce2d9456f12021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238015

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
36a282d2-7285-442b-9574-dfce2d9456f1norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral TabletPSN15Balziva ® (norethindrone and ethinyl estradiol tablets USP )20211231
36a282d2-7285-442b-9574-dfce2d9456f1ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral TabletSCD15Balziva ® (norethindrone and ethinyl estradiol tablets USP )20211231
c0e2c5b4-70ac-4b41-aa71-00e506dbb72fethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral TabletSCD13BRIELLYN ® (Norethindrone and Ethinyl Estradiol Tablets, USP)20260131
c0e2c5b4-70ac-4b41-aa71-00e506dbb72fnorethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral TabletPSN13BRIELLYN ® (Norethindrone and Ethinyl Estradiol Tablets, USP)20260131
77b8d3ef-f3ac-4148-84f0-f6cb327c9f78ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral TabletSCD8PHILITH TM (Norethindrone and Ethinyl Estradiol Tablets, USP) 0.4 mg/0.035 mg 28-Day Regimen Rx Only20251205
77b8d3ef-f3ac-4148-84f0-f6cb327c9f78norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral TabletPSN8PHILITH TM (Norethindrone and Ethinyl Estradiol Tablets, USP) 0.4 mg/0.035 mg 28-Day Regimen Rx Only20251205
175ce5c4-d332-4c97-a0b8-10821dc813efnorethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral TabletPSN6Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) 0.4 mg/0.035 mg20251119
175ce5c4-d332-4c97-a0b8-10821dc813efethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral TabletSCD6Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) 0.4 mg/0.035 mg20251119
dea10e78-0e7b-4404-9c3a-ed2447a1788bnorethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral TabletPSN3Rhuzdah (norethindrone and ethinyl estradiol tablets, USP) 0.4 mg/0.035 mg 28-Day Regimen Rx only20231123
dea10e78-0e7b-4404-9c3a-ed2447a1788bethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral TabletSCD3Rhuzdah (norethindrone and ethinyl estradiol tablets, USP) 0.4 mg/0.035 mg 28-Day Regimen Rx only20231123
6fc9aa72-6289-4ce1-8b41-b132307564fdethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral TabletSCD3Balziva ® (norethindrone and ethinyl estradiol tablets USP )20230607
6fc9aa72-6289-4ce1-8b41-b132307564fdnorethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral TabletPSN3Balziva ® (norethindrone and ethinyl estradiol tablets USP )20230607
3c247e9d-fff8-40e8-a9d3-88adee3426e2ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral TabletSCD1Zenchent® 0.4/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg, 28-Day)20100813
3c247e9d-fff8-40e8-a9d3-88adee3426e2norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral TabletPSN1Zenchent® 0.4/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg, 28-Day)20100813