FDA.reportPublic FDA data

{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day]

RxCUI
1365899
RxNorm name
{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day]
Display name
{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day]
Full name
{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day]
Term type
BPCK
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1365899
Mono-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLC84a20017-344b-4684-a915-c85a55fcbbcb2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1365899

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
84a20017-344b-4684-a915-c85a55fcbbcb{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day] [BPCK] · MONO-LINYAH 28 Day Pack [PSN] · Mono-Linyah 28 Day Pack [SY]39These highlights do not include all the information needed to use Mono-Linyah safely and effectively. See full prescribing information for Mono-Linyah. Mono-Linyah (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval:198920250120
2ec8f18f-297c-405f-b191-a40767366bad{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day] [BPCK] · MONO-LINYAH 28 Day Pack [PSN] · Mono-Linyah 28 Day Pack [SY]36These highlights do not include all the information needed to use Mono-Linyah safely and effectively. See full prescribing information for Mono-Linyah. Mono-Linyah (norgestimate/ethinyl estradiol tablets) for oral use. Initial U.S. Approval:198920240507