Is Norethisterone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Norethisterone, including PRIMOLUT N TAB 5 MG (5 mg, Tablet, SAR 18.40).

Is Norethisterone approved by the US FDA?

Drugs@FDA lists 25 application product lines for Norethisterone, including NOR-QD (Prescription); NORETHINDRONE ACETATE (Prescription); CAMILA (Prescription); ERRIN (Prescription); HEATHER (Prescription).

Is Norethisterone on the WHO Model List of Essential Medicines?

Yes — 18.4. Progestogens (core list): Therapeutic equivalent to medroxyprogesterone acetate for Excessive menstruation with irregular cycle.

Are there safety signals or safety updates for Norethisterone?

US FDA: 30 entries (latest 2025-07-29).

Active substance

Norethisterone

SFDA 1
US FDA 25
Health Canada 4
US price lines 8
NHS prices 3
WHO EML 1
Safety 30

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PRIMOLUT N TAB 5 MG	5 mg	Tablet · Oral use	30 Blister	SAR 18.40	NCE · Prescription	BAYER AG	Valid

Indications — CHI Daman Drug Formulary

ENDOMETRIOSIS; MENSTRUAL DISORDERS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NOR-QD	0.35MG	tablet · oral-28	TEVA BRANDED PHARM	Prescription	2 Jan 1973
NORETHINDRONE ACETATE	5MG	tablet · oral	BARR	Prescription	25 May 2001
CAMILA	0.35MG	tablet · oral-28	DR REDDYS LABS SA	Prescription	21 Oct 2002
ERRIN	0.35MG	tablet · oral-28	DR REDDYS LABS SA	Prescription	21 Oct 2002
HEATHER	0.35MG	tablet · oral-28	GLENMARK PHARMS LTD	Prescription	23 Apr 2010
NORETHINDRONE ACETATE	5MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	21 Jul 2010
NORETHINDRONE	0.35MG	tablet · oral-28	GLENMARK PHARMS LTD	Prescription	22 Jul 2010
NORETHINDRONE	0.35MG	tablet · oral-28	LUPIN LTD	Prescription	19 Sep 2011
NORETHINDRONE ACETATE	5MG	tablet · oral	AMNEAL PHARMS	Prescription	30 Jul 2012
JENCYCLA	0.35MG	tablet · oral-28	LUPIN LTD	Prescription	28 Mar 2013
NORETHINDRONE	0.35MG	tablet · oral-28	XIROMED	Prescription	12 Jun 2013
NORETHINDRONE	0.35MG	tablet · oral-28	XIROMED	Prescription	24 Jun 2013
NORETHINDRONE	0.35MG	tablet · oral-28	NOVAST LABS	Prescription	13 Sep 2013
NORETHINDRONE	0.35MG	tablet · oral-28	NOVAST LABS	Prescription	13 Sep 2013
INCASSIA	0.35MG	tablet · oral-28	AUROBINDO PHARMA	Prescription	23 Sep 2016
NORETHINDRONE ACETATE	5MG	tablet · oral	XIROMED	Prescription	10 Nov 2016
NORETHINDRONE	0.35MG	tablet · oral-28	NAARI PTE	Prescription	13 Dec 2016
NORETHINDRONE ACETATE	5MG	tablet · oral	INGENUS PHARMS LLC	Prescription	5 Nov 2018
EMZAHH	0.35MG	tablet · oral-28	AUROBINDO PHARMA	Prescription	6 Jan 2023
MICRONOR	0.35MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral-28	JANSSEN PHARMS	Discontinued	2 Jan 1973
AYGESTIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	DURAMED RES	Discontinued	21 Apr 1982
NORETHINDRONE	0.35MG	tablet · oral-28	AMNEAL PHARMS	Discontinued	1 Aug 2013
NORETHINDRONE ACETATE	5MG	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	8 Jan 2016
NORLUTIN	5MG	tablet · oral	PARKE DAVIS	Discontinued
NORLUTATE	5MG	tablet · oral	PARKE DAVIS	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JENCYCLA	02441306	0.35 MG	TABLET · ORAL	LUPIN PHARMA CANADA LIMITED
MAEVE	02458683	0.35 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
MOVISSE	02410303	0.35 MG	TABLET · ORAL	SENADOR LABORATORIES PRIVATE LIMITED
NORLUTATE	00023760	5 MG	TABLET · ORAL	SEARCHLIGHT PHARMA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CAMILA 0.35 MG TABLET	$0.09243	per EA	23 Sep 2026
US NADAC	EMZAHH 0.35 MG TABLET	$0.09243	per EA	23 Sep 2026
US NADAC	ERRIN 0.35 MG TABLET	$0.09243	per EA	23 Sep 2026
US NADAC	HEATHER 0.35 MG TABLET	$0.09243	per EA	23 Sep 2026
US NADAC	INCASSIA 0.35 MG TABLET	$0.09243	per EA	23 Sep 2026
US NADAC	JENCYCLA 0.35 MG TABLET	$0.09243	per EA	23 Sep 2026
US NADAC	NORETHINDRONE 0.35 MG TABLET	$0.09243	per EA	23 Sep 2026
US NADAC	NORETHINDRONE 5 MG TABLET	$0.28984	per EA	23 Sep 2026
NHS Drug Tariff	Norethisterone 200mg/1ml solution for injection ampoules	£4.05	1 ampoule	1 Oct 2026
NHS Drug Tariff	Norethisterone 350microgram tablets	£2.10	84 tablet	1 Oct 2026
NHS Drug Tariff	Norethisterone 5mg tablets	£6.39	30 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

18.4. Progestogens · core
Therapeutic equivalent to medroxyprogesterone acetate for Excessive menstruation with irregular cycle

Safety signals and safety-related labeling changes

US FDA 29 Jul 2025 FEMLYV — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Feb 2024 ACTIVELLA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Feb 2024 COMBIPATCH — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 9 Aug 2023 LUPANETA PACK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Jun 2023 MINASTRIN 24 FE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Jun 2023 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Jun 2023 TAYTULLA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 May 2023 FEMHRT — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Jan 2023 LOESTRIN 21 1.5/30 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Jan 2023 LOESTRIN 21 1/20 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Jan 2023 LOESTRIN 24 FE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Jan 2023 LOESTRIN FE 1.5/30 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Jan 2023 LOESTRIN FE 1/20 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Apr 2022 ESTROSTEP FE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Apr 2022 NORINYL 1+35 21-DAY — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for norethisterone →

Combinations containing Norethisterone

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.