Is Cefprozil 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 Cefprozil, including CEFPROZ 125MG-5ML POWDER FOR ORAL SUSP (25 mg/ml, Powder for oral suspension, SAR 18.95); CEFPROZ 250MG-5ML POWDR FOR ORAL SUSP (50 mg/ml, Powder for oral suspension, SAR 32.25); CEFPROZ 250MG/5ML POWDER FOR ORAL SUSPENSION (50 mg/ml, Powder for oral suspension, SAR 64.50).

Is Cefprozil approved by the US FDA?

Drugs@FDA lists 18 application product lines for Cefprozil, including CEFPROZIL (Prescription); CEFPROZIL (Prescription); CEFPROZIL (Prescription); CEFPROZIL (Prescription); CEFPROZIL (Prescription).

Active substance

Cefprozil

SFDA 7
US FDA 18
Health Canada 7
US price lines 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CEFPROZ 125MG-5ML POWDER FOR ORAL SUSP	25 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 18.95	Generic · Prescription	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Valid
CEFPROZ 250MG-5ML POWDR FOR ORAL SUSP	50 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 32.25	Generic · Prescription	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Valid
CEFPROZ 250MG/5ML POWDER FOR ORAL SUSPENSION	50 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 64.50	Generic · Prescription	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Valid
CEFZIL 125MG-5ML SUSP	25 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 27.10	NCE · Prescription	BRISTOL - MYERS SQUIBB /PFIZER EEIG	Withdrawn by MAH · Not Marketed
CEFZIL 250MG TAB	250 mg	Tablet · Oral use	10 Blister	SAR 51.10	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
CEFZIL 250MG-5ML SUSP	50 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 46.05	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
CEFZIL 500MG TAB	500 mg	Tablet · Oral use	10 Blister	SAR 79.70	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

INTRA-ABDOMINAL INFECTIONS; LOWER URINARY TRACT INFECTIONS; OTITIS MEDIA; SICKLE CELL DISEASE - ACS MANAGEMENT

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

Product	Strength	Form · route	Applicant	Status	First approved
CEFPROZIL	250MG; 500MG	tablet · oral	CHARTWELL RX	Prescription	14 Nov 2005
CEFPROZIL	250MG; 500MG	tablet · oral	TEVA	Prescription	6 Dec 2005
CEFPROZIL	250MG; 500MG	tablet · oral	LUPIN	Prescription	8 Dec 2005
CEFPROZIL	125MG/5ML; 250MG/5ML	for suspension · oral	LUPIN	Prescription	19 Dec 2005
CEFPROZIL	125MG/5ML; 250MG/5ML	for suspension · oral	AUROBINDO PHARMA	Prescription	30 Jan 2007
CEFPROZIL	250MG; 500MG	tablet · oral	AUROBINDO PHARMA	Prescription	24 May 2007
CEFPROZIL	250MG; 500MG	tablet · oral	ALKEM LABS LTD	Prescription	9 Apr 2024
CEFZIL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	CORDEN PHARMA	Discontinued	23 Dec 1991
CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	for suspension · oral	CORDEN PHARMA	Discontinued	23 Dec 1991
CEFPROZIL	125MG/5ML; 250MG/5ML	for suspension · oral	CHARTWELL RX	Discontinued	8 Dec 2005
CEFPROZIL	125MG/5ML; 250MG/5ML	for suspension · oral	SANDOZ	Discontinued	8 Dec 2005
CEFPROZIL	250MG; 500MG	tablet · oral	ORCHID HLTHCARE	Discontinued	19 Dec 2005
CEFPROZIL	250MG/5ML; 125MG/5ML	for suspension · oral	ORCHID HLTHCARE	Discontinued	30 Dec 2005
CEFPROZIL	125MG/5ML; 250MG/5ML	for suspension · oral	RANBAXY LABS LTD	Discontinued	30 Jun 2006
CEFPROZIL	250MG; 500MG	tablet · oral	RANBAXY LABS LTD	Discontinued	13 Dec 2006
CEFPROZIL	250MG; 500MG	tablet · oral	WOCKHARDT	Discontinued	14 Jun 2007
CEFPROZIL	250MG; 500MG	tablet · oral	APOTEX INC	Discontinued	26 Mar 2008
CEFPROZIL	125MG/5ML; 250MG/5ML	for suspension · oral	APOTEX INC	Discontinued	29 Feb 2012

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-CEFPROZIL	02347253	500 MG	TABLET · ORAL	AURO PHARMA INC
AURO-CEFPROZIL	02347261	125 MG / 5 ML	POWDER FOR SUSPENSION · ORAL	AURO PHARMA INC
AURO-CEFPROZIL	02347288	250 MG / 5 ML	POWDER FOR SUSPENSION · ORAL	AURO PHARMA INC
SPC-CEFPROZIL	02293528	250 MG	TABLET · ORAL	SUN PHARMA CANADA INC
SPC-CEFPROZIL	02293536	500 MG	TABLET · ORAL	SUN PHARMA CANADA INC
SPC-CEFPROZIL	02293579	250 MG / 5 ML	POWDER FOR SUSPENSION · ORAL	SUN PHARMA CANADA INC
SPC-CEFPROZIL	02329204	125 MG / 5 ML	POWDER FOR SUSPENSION · ORAL	SUN PHARMA CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CEFPROZIL 125 MG/5 ML SUSP	$0.1049	per ML	23 Sep 2026
US NADAC	CEFPROZIL 125 MG/5 ML SUSP	$0.17606	per ML	23 Sep 2026
US NADAC	CEFPROZIL 125 MG/5 ML SUSP	$0.12065	per ML	23 Sep 2026
US NADAC	CEFPROZIL 250 MG TABLET	$0.4821	per EA	23 Sep 2026
US NADAC	CEFPROZIL 250 MG/5 ML SUSP	$0.22766	per ML	23 Sep 2026
US NADAC	CEFPROZIL 250 MG/5 ML SUSP	$0.20641	per ML	23 Sep 2026
US NADAC	CEFPROZIL 250 MG/5 ML SUSP	$0.15109	per ML	7 Oct 2026
US NADAC	CEFPROZIL 500 MG TABLET	$0.92524	per EA	23 Sep 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.

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.