Is Carbidopa + Levodopa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Carbidopa + Levodopa, including Carbidopa and Levodopa Qo (100,25 mg,mg, Tablet, SAR 40.05); DUODOPA intestinal gel (20,5 mg,mg, Gel, SAR 5566.00); Zydolev (25,250 mg,mg, Tablet, SAR 41.90).

Is Carbidopa + Levodopa approved by the US FDA?

Drugs@FDA lists 39 application product lines for Carbidopa + Levodopa, including SINEMET (Prescription); CARBIDOPA AND LEVODOPA (Prescription); CARBIDOPA AND LEVODOPA (Prescription); CARBIDOPA AND LEVODOPA (Prescription); CARBIDOPA AND LEVODOPA (Prescription).

Is Carbidopa + Levodopa authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Carbidopa + Levodopa: Onerji, Hopledo.

Is Carbidopa + Levodopa on the WHO Model List of Essential Medicines?

Yes — 5.1.3. Medicines for parkinsonism (core list): Parkinson disease.

Active substances

Carbidopa + Levodopa

SFDA 7
US FDA 39
EMA 3
Health Canada 20
US price lines 13
NHS prices 6
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Carbidopa and Levodopa Qo	100,25 mg,mg	Tablet · Oral use	30 Blister	SAR 40.05	Generic · Prescription	Qomel Co	Valid
DUODOPA intestinal gel	20,5 mg,mg	Gel · Inhalation use	7 Bag	SAR 5566.00	NCE · Prescription	Abbvie Limited	Valid
Zydolev	25,250 mg,mg	Tablet · Oral use	30 Blister	SAR 41.90	Generic · Prescription	Zydus Lifesciences Limited	Valid
SINEMET 25-250MG TABLETS	250,25 mg,mg	Tablet · Oral use	20 Blister	SAR 44.25	Generic · Prescription	Algorithm SAL	Suspended
SINEMET-110 TAB	10, 100 mg	Tablet · Oral use	100 Tablet Container	SAR 59.75	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
SINEMET-275 TAB	25, 250 mg	Tablet · Oral use	100 Tablet Container	SAR 87.25	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
SINEMET-PLUS	25, 100 mg	Tablet · Oral use	100 Tablet Container	SAR 74.60	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HUNTINGTON'S DISEASE; SPASTICITY

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

Product	Strength	Form · route	Applicant	Status	First approved
SINEMET	10MG;100MG; 25MG;250MG; 25MG;100MG	tablet · oral	ORGANON	Prescription	2 May 1975
CARBIDOPA AND LEVODOPA	25MG;100MG	tablet · oral	DR REDDYS LABS SA	Prescription	28 Aug 1992
CARBIDOPA AND LEVODOPA	25MG;250MG	tablet · oral	DR REDDYS LABS SA	Prescription	28 Aug 1992
CARBIDOPA AND LEVODOPA	10MG;100MG	tablet · oral	DR REDDYS LABS SA	Prescription	28 Aug 1992
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet · oral	ACTAVIS ELIZABETH	Prescription	3 Sep 1993
CARBIDOPA AND LEVODOPA	50MG;200MG; 25MG;100MG	tablet, extended release · oral	MYLAN	Prescription	30 Sep 1999
CARBIDOPA AND LEVODOPA	25MG;100MG; 50MG;200MG	tablet, extended release · oral	IMPAX LABS	Prescription	14 May 2004
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet, orally disintegrating · oral	RISING	Prescription	18 Sep 2008
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet · oral	SUN PHARM INDS	Prescription	28 Oct 2008
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet, orally disintegrating · oral	SUN PHARM	Prescription	31 Jul 2009
CARBIDOPA AND LEVODOPA	25MG;100MG	tablet · oral	PHARMOBEDIENT	Prescription	28 Sep 2009
CARBIDOPA AND LEVODOPA	25MG;100MG; 50MG;200MG	tablet, extended release · oral	ACCORD HLTHCARE	Prescription	8 Feb 2013
RYTARY	23.75MG;95MG; 36.25MG;145MG; 48.75MG;195MG; 61.25MG;245MG	capsule, extended release · oral	IMPAX	Prescription	7 Jan 2015
DUOPA	4.63MG/ML;20MG/ML	suspension · enteral	ABBVIE	Prescription	9 Jan 2015
CARBIDOPA AND LEVODOPA	25MG;100MG; 50MG;200MG	tablet, extended release · oral	ALEMBIC	Prescription	5 Jun 2019
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet · oral	SCIEGEN PHARMS	Prescription	7 May 2021
CARBIDOPA AND LEVODOPA	25MG;100MG; 50MG;200MG	tablet, extended release · oral	SCIEGEN PHARMS	Prescription	5 Oct 2021
DHIVY	25MG;100MG	tablet · oral	AVION PHARMS	Prescription	12 Nov 2021
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet · oral	RUBICON RESEARCH	Prescription	21 Sep 2022
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	28 Nov 2022
CARBIDOPA AND LEVODOPA	25MG;100MG; 50MG;200MG	tablet, extended release · oral	RUBICON RESEARCH	Prescription	4 Jun 2024
CREXONT	35MG;140MG; 52.5MG;210MG; 70MG;280MG; 87.5MG;350MG	capsule, extended release · oral	IMPAX	Prescription	7 Aug 2024
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet · oral	ASCENT PHARMS INC	Prescription	14 Jan 2025
SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	ORGANON LLC	Discontinued	30 May 1991
CARBIDOPA AND LEVODOPA	10MG;100MG; 25MG;100MG; 25MG;250MG	tablet · oral	SCS	Discontinued	25 Mar 1994

14 more — full table

EMA European Union — centrally authorised medicines

Onerji Tanabe Pharma GmbH · Authorised · authorised 27 Apr 2026 · ATC N04BA02

Therapeutic indication (EMA)

Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.

Hopledo Zambon SpA · Authorised · authorised 20 Aug 2026 · ATC N04BA02

Therapeutic indication (EMA)

Hopledo is indicated for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilised with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens.

Numient Amneal Pharma Europe Ltd · Withdrawn · authorised 19 Nov 2015 · ATC N04BA02

Therapeutic indication (EMA)

Symptomatic treatment of adult patients with Parkinson’s disease

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AA-LEVOCARB CR	02245211	200 MG; 50 MG	TABLET (EXTENDED-RELEASE) · ORAL	AA PHARMA INC
AA-LEVOCARB CR	02272873	25 MG; 100 MG	TABLET (EXTENDED-RELEASE) · ORAL	AA PHARMA INC
AG-LEVOCARB	02551365	25 MG; 100 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-LEVOCARB	02195933	100 MG; 10 MG	TABLET · ORAL	APOTEX INC
APO-LEVOCARB	02195941	25 MG; 100 MG	TABLET · ORAL	APOTEX INC
APO-LEVOCARB	02195968	250 MG; 25 MG	TABLET · ORAL	APOTEX INC
AURO-LEVOCARB	02531593	100 MG; 10 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LEVOCARB	02531607	100 MG; 25 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LEVOCARB	02531615	25 MG; 250 MG	TABLET · ORAL	AURO PHARMA INC
DUODOPA	02292165	5 MG / ML; 20 MG / ML	GEL · INTRAINTESTINAL (UPPER)	ABBVIE CORPORATION
JAMP LEVOCARB	02546396	100 MG; 10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP LEVOCARB	02546418	100 MG; 25 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP LEVOCARB	02546426	25 MG; 250 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MINT-LEVOCARB	02457954	100 MG; 10 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-LEVOCARB	02457962	25 MG; 100 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
PMS-LEVODOPA-CARBIDOPA	02549719	100 MG; 10 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-LEVODOPA-CARBIDOPA	02549727	25 MG; 100 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-LEVODOPA-CARBIDOPA	02549735	250 MG; 25 MG	TABLET · ORAL	PHARMASCIENCE INC
TEVA-LEVOCARBIDOPA	02244495	100 MG; 25 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-LEVOCARBIDOPA	02244496	250 MG; 25 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CARBIDOPA-LEVODOPA 10-100 TAB	$0.06826	per EA	23 Sep 2026
US NADAC	CARBIDOPA-LEVODOPA 25-100 TAB	$0.07589	per EA	23 Sep 2026
US NADAC	CARBIDOPA-LEVODOPA 25-250 TAB	$0.11894	per EA	23 Sep 2026
US NADAC	CREXONT ER 35 MG-140 MG CAP	$4.58989	per EA	1 Jul 2026
US NADAC	CREXONT ER 52.5 MG-210 MG CAP	$4.5824	per EA	1 Jul 2026
US NADAC	CREXONT ER 70 MG-280 MG CAP	$4.58002	per EA	1 Jul 2026
US NADAC	CREXONT ER 87.5 MG-350 MG CAP	$4.58252	per EA	1 Jul 2026
US NADAC	DHIVY 25-100 MG TABLET	$3.61409	per EA	1 Jan 2026
US NADAC	RYTARY ER 23.75 MG-95 MG CAP	$3.98069	per EA	23 Sep 2026
US NADAC	RYTARY ER 36.25 MG-145 MG CAP	$3.9763	per EA	23 Sep 2026
US NADAC	RYTARY ER 48.75 MG-195 MG CAP	$3.98378	per EA	23 Sep 2026
US NADAC	RYTARY ER 61.25 MG-245 MG CAP	$4.99716	per EA	23 Sep 2026
NHS Drug Tariff	Co-careldopa 10mg/100mg tablets	£14.00	100 tablet	1 Oct 2026
NHS Drug Tariff	Co-careldopa 12.5mg/50mg tablets	£5.60	90 tablet	1 Oct 2026
NHS Drug Tariff	Co-careldopa 25mg/100mg modified-release tablets	£11.60	60 tablet	1 Oct 2026
NHS Drug Tariff	Co-careldopa 25mg/100mg tablets	£6.28	100 tablet	1 Oct 2026
NHS Drug Tariff	Co-careldopa 25mg/250mg tablets	£35.00	100 tablet	1 Oct 2026
NHS Drug Tariff	Co-careldopa 50mg/200mg modified-release tablets	£11.60	60 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)

5.1.3. Medicines for parkinsonism · core
Parkinson disease
Oral > Solid: 100 mg + 10 mg tablet; 250 mg + 25 mg tablet; 100 mg + 25 mg tablet

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.