FDA.reportPublic FDA data

{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack

RxCUI
749736
RxNorm name
{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
Display name
{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
Full name
{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
Term type
GPCK
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#

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
BRIELLYNNORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAc0e2c5b4-70ac-4b41-aa71-00e506dbb72f2026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 749736
PhilithNORETHINDRONE AND ETHINYL ESTRADIOL TABLETSNorthstar Rx LLC77b8d3ef-f3ac-4148-84f0-f6cb327c9f782025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 749736
VyfemlaNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.175ce5c4-d332-4c97-a0b8-10821dc813ef2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749736
RhuzdahNORETHINDRONE AND ETHINYL ESTRADIOL TABLETAurobindo Pharma Limiteddea10e78-0e7b-4404-9c3a-ed2447a1788b2023-11-23Warnings, Adverse reactionsExact identifier
rxcui: 749736
BalzivaNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.36a282d2-7285-442b-9574-dfce2d9456f12021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 749736

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
36a282d2-7285-442b-9574-dfce2d9456f1{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Noreth 0.035-0.4 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack [PSN]215Balziva ® (norethindrone and ethinyl estradiol tablets USP )20211231
c0e2c5b4-70ac-4b41-aa71-00e506dbb72f{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Noreth 0.035-0.4 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack [PSN]213BRIELLYN ® (Norethindrone and Ethinyl Estradiol Tablets, USP)20260131
77b8d3ef-f3ac-4148-84f0-f6cb327c9f78{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Noreth 0.035-0.4 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack [PSN]28PHILITH TM (Norethindrone and Ethinyl Estradiol Tablets, USP) 0.4 mg/0.035 mg 28-Day Regimen Rx Only20251205
175ce5c4-d332-4c97-a0b8-10821dc813ef{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Noreth 0.035-0.4 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack [PSN]26Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) 0.4 mg/0.035 mg20251119
dea10e78-0e7b-4404-9c3a-ed2447a1788b{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Noreth 0.035-0.4 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack [PSN]23Rhuzdah (norethindrone and ethinyl estradiol tablets, USP) 0.4 mg/0.035 mg 28-Day Regimen Rx only20231123
6fc9aa72-6289-4ce1-8b41-b132307564fd{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Noreth 0.035-0.4 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack [PSN]23Balziva ® (norethindrone and ethinyl estradiol tablets USP )20230607
3c247e9d-fff8-40e8-a9d3-88adee3426e2{21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [GPCK] · Eth estra-Noreth 0.035-0.4 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack [PSN]21Zenchent® 0.4/35 (Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg, 28-Day)20100813