FDA.reportPublic FDA data

NORETHINDRONE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2017-05-01
Label type
Indexing - product concept
Version
3
Source
full-release
Hydrated at
2026-06-05 00:16:57

Label at a glance#

ProductNORETHINDRONE
Active ingredientNORETHINDRONE, ETHINYL ESTRADIOL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
NORETHINDRONET18F433X4SACTIB
ETHINYL ESTRADIOL423D2T571UACTIB

Source Document#

Source XML

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorethindroneNORETHINDRONEGlenmark Pharmaceuticals Inc., USA0d2f8fea-3675-40d2-afd9-9fcb148dbd4b2026-01-31Warnings, Adverse reactionsName fallback
brand name: Norethindrone
generic name: NORETHINDRONE
HEATHERNORETHINDRONEGlenmark Pharmaceuticals Inc., USA35b5ddb5-1729-4588-b2a2-ead56d78b6f92026-01-23Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
NORETHINDRONENORETHINDRONEProficient Rx LPbbd54f1e-2d48-4efa-a57e-7fa7b478c4572026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NORETHINDRONE
generic name: NORETHINDRONE
JencyclaNORETHINDRONELupin Pharmaceuticals, Inc.e91e7bdd-2984-4332-9b0b-04322792d7f62025-12-08Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
DEBLITANENORETHINDRONENorthstar Rx LLCe75367ff-78af-4bd2-a99d-d291cb1d21eb2025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
SHAROBELNORETHINDRONENorthstar Rx LLCa96f5194-ad2a-4783-a9a9-22a288caff252025-12-05Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
Norethindrone AcetateNORETHINDRONEAvKARE827c7ef1-a8b7-d0c4-b062-c5154b331a352025-09-17Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
MELEYANORETHINDRONEXiromed LLC534c5717-382c-4109-3208-e21b32e4c4c92025-03-06Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
NORETHINDRONENORETHINDRONELupin Pharmaceuticals, Inc.121fbf86-1d76-4579-be2f-be9a957b23ab2025-02-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NORETHINDRONE
generic name: NORETHINDRONE
NORETHINDRONENORETHINDRONEA-S Medication Solutions70231aa1-9dd2-420f-9cb3-432d3c2477d12025-02-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NORETHINDRONE
generic name: NORETHINDRONE
OrquideaNORETHINDRONEXiromed, LLC6e9f61a1-93ff-291a-bea8-9307a3b0378e2025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
Norethindrone AcetateNORETHINDRONEAmneal Pharmaceuticals LLC64cb920c-36e8-4d62-9d08-3ddf3989d3132024-10-30Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
AffodelNORETHINDRONENaari Pte. Limited8ec64ec8-fbc9-440d-9838-654a605d57da2024-04-22Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
CAMILANORETHINDRONEDr. Reddy's Labratories Inc.59985565-af09-21ba-0336-3f6db7711bd12024-04-01Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
ERRINNORETHINDRONEDr. Reddy's Labratories Inc.df29577b-c2f0-bea8-b048-7719972707aa2024-03-01Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
ERRINNORETHINDRONEProficient Rx LP904899f2-9c54-44d2-901e-47e8945715002024-01-01Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
EmzahhNORETHINDRONEAurobindo Pharma Limited197d31d3-eec8-49c7-9640-918ff138fea22023-04-10Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
LyleqNORETHINDRONEAfaxys Pharma, LLCc9f00a3e-c827-4066-bf85-079b3a20f25e2023-03-27Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
IncassiaNORETHINDRONEAurobindo Pharma Limited0b87cef0-610c-469d-92ba-4007f4bc38782021-09-14Warnings, Adverse reactionsName fallback
generic name: NORETHINDRONE
NorethindroneNORETHINDRONEProficient Rx LPfb84b86e-5f1f-4c17-8b69-ff695c5faf552019-11-01Warnings, Adverse reactionsName fallback
brand name: Norethindrone
generic name: NORETHINDRONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.