Is Ethinylestradiol + Norgestimate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Ethinylestradiol + Norgestimate.

Is Ethinylestradiol + Norgestimate approved by the US FDA?

Drugs@FDA lists 41 application product lines for Ethinylestradiol + Norgestimate, including SPRINTEC (Prescription); TRI-SPRINTEC (Prescription); ORTHO TRI-CYCLEN 21 (Prescription); ORTHO TRI-CYCLEN 28 (Prescription); TRI LO SPRINTEC (Prescription).

Active substances

Ethinylestradiol + Norgestimate

SFDA 1
US FDA 41
Health Canada 6
US price lines 10
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CILEST TAB	0.035, 0.250 mg	Tablet · Oral use	21 Blister	SAR 16.50	NCE · Prescription	Janssen-Cilag International NV	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
SPRINTEC	0.035MG;0.25MG	tablet · oral-28	BARR	Prescription	25 Sep 2002
TRI-SPRINTEC	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	BARR	Prescription	29 Dec 2003
ORTHO TRI-CYCLEN 21	0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG	tablet · oral-21	ORTHO MCNEIL PHARM	Prescription	13 May 2005
ORTHO TRI-CYCLEN 28	0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG	tablet · oral-28	ORTHO MCNEIL PHARM	Prescription	13 May 2005
TRI LO SPRINTEC	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	BARR LABS INC	Prescription	29 Jun 2009
NORGESTIMATE; ETHINYL ESTRADIOL	0.215MG; 0.025MG; 0.25MG; 0.025MG	tablet · oral	WATSON LABS	Prescription	9 Mar 2011
NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	GLENMARK PHARMS LTD	Prescription	17 Jun 2011
NORGESTIMATE; ETHINYL ESTRADIOL	0.215MG; 0.035MG; 0.25MG; 0.035MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	17 Jun 2011
NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG;0.25MG	tablet · oral-28	GLENMARK PHARMS LTD	Prescription	5 Apr 2012
MONO-LINYAH	0.035MG;0.25MG	tablet · oral-28	NOVAST LABS LTD	Prescription	23 May 2012
TRI-LINYAH	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	NOVAST LABS LTD	Prescription	30 May 2012
NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	LUPIN PHARMS	Prescription	25 Jun 2012
TRI-ESTARYLLA	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	XIROMED	Prescription	30 Jan 2013
ESTARYLLA	0.035MG;0.25MG	tablet · oral-28	XIROMED	Prescription	30 Jan 2013
NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	NAARI PTE	Prescription	7 Apr 2015
NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG;0.25MG	tablet · oral-28	NAARI PTE	Prescription	7 Apr 2015
TRI-LO-ESTARYLLA	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	XIROMED	Prescription	29 Jun 2015
NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	GLENMARK SPECLT	Prescription	23 Feb 2016
NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	LUPIN	Prescription	26 Apr 2016
NORGESTIMATE AND ETHINYL ESTRADIOL	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	NAARI PTE	Prescription	12 May 2016
TRI-MILI	0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	AUROBINDO PHARMA LTD	Prescription	6 Jul 2016
MILI	0.035MG;0.25MG	tablet · oral-28	AUROBINDO PHARMA LTD	Prescription	7 Jul 2016
NORGESTIMATE AND ETHINYL ESTRADIOL	0.035MG;0.25MG	tablet · oral-28	LUPIN	Prescription	27 Oct 2016
TRI-LO-MILI	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	AUROBINDO PHARMA	Prescription	4 Nov 2016
TRI-LO-LINYAH	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	tablet · oral-28	NOVAST LABS	Prescription	2 Sep 2022

16 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRI-CIRA 21	02508087	0.215 MG; 0.035 MG; 0.25 MG; 0.18 MG	TABLET · ORAL	APOTEX INC
TRI-CIRA 28	02508095	0.035 MG; 0.18 MG; 0.215 MG; 0.25 MG	TABLET · ORAL	APOTEX INC
TRI-CIRA LO 21	02401967	0.025 MG; 0.25 MG; 0.215 MG; 0.18 MG	TABLET · ORAL	APOTEX INC
TRI-CIRA LO 28	02401975	0.025 MG; 0.25 MG; 0.18 MG; 0.215 MG	TABLET · ORAL	APOTEX INC
TRI-JORDYNA 21	02486296	0.035 MG; 0.18 MG; 0.25 MG; 0.215 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
TRI-JORDYNA 28	02486318	0.035 MG; 0.215 MG; 0.18 MG; 0.25 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ESTARYLLA 0.25-0.035 MG TABLET	$0.11481	per EA	23 Sep 2026
US NADAC	MILI 0.25-0.035 MG TABLET	$0.11481	per EA	23 Sep 2026
US NADAC	SPRINTEC 28 DAY TABLET	$0.11481	per EA	23 Sep 2026
US NADAC	TRI-ESTARYLLA TABLET	$0.12642	per EA	23 Sep 2026
US NADAC	TRI-LINYAH TABLET	$0.12642	per EA	23 Sep 2026
US NADAC	TRI-LO-ESTARYLLA TABLET	$0.10804	per EA	23 Sep 2026
US NADAC	TRI-LO-MILI TABLET	$0.10804	per EA	23 Sep 2026
US NADAC	TRI-LO-SPRINTEC TABLET	$0.10804	per EA	23 Sep 2026
US NADAC	TRI-MILI 28 TABLET	$0.12642	per EA	23 Sep 2026
US NADAC	TRI-SPRINTEC TABLET	$0.12642	per EA	23 Sep 2026
NHS Drug Tariff	Ethinylestradiol 35microgram / Norgestimate 250microgram tablets	£4.65	63 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.

Components

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.