Is Cefdinir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 18 valid registrations of Cefdinir, including DENACIF 125 mg/5 ml Suspension (25 mg/ml, Powder for oral suspension, SAR 41.40); DENACIF 300 mg Capsule (300 mg, Capsule, SAR 57.80); MINOCET 125 mg/5 ml powder for oral suspension (25 mg/ml, Oral suspension, SAR 58.05); MINOCET 300 mg capsule (300 mg, Capsule, hard, SAR 64.20); OMNICEF 125MG-5ML SUSP (25 mg/ml, Suspension, SAR 71.50).

Is Cefdinir approved by the US FDA?

Drugs@FDA lists 14 application product lines for Cefdinir, including CEFDINIR (Prescription); CEFDINIR (Prescription); CEFDINIR (Prescription); CEFDINIR (Prescription); CEFDINIR (Prescription).

Active substance

Cefdinir

SFDA 18
US FDA 14
US price lines 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DENACIF 125 mg/5 ml Suspension	25 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 41.40	Generic · Prescription	Med City Pharma	Valid
DENACIF 125 mg/5 ml Suspension	25 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 64.75	Generic · Prescription	Med City Pharma	Valid
DENACIF 300 mg Capsule	300 mg	Capsule · Oral use	10 Bottle	SAR 57.80	Generic · Prescription	Med City Pharma	Valid
MINOCET 125 mg/5 ml powder for oral suspension	25 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 58.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
MINOCET 125 mg/5 ml powder for oral suspension	25 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 37.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
MINOCET 300 mg capsule	300 mg	Capsule, hard · Oral use	10 Bottle	SAR 64.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
OMNICEF 125MG-5ML SUSP	25 mg/ml	Suspension · Oral use	1 Bottle	SAR 71.50	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
OMNICEF 125MG-5ML SUSP	25 mg/ml	Suspension · Oral use	1 Bottle	SAR 45.80	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
OMNICEF 300MG CAPSULE	300 mg	Capsule · Oral use	10 Blister	SAR 79.05	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Omnicef	600 mg	Film-coated tablet · Oral use	10 Bottle	SAR 129.65	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Omnicef 250mg/5ml Suspension	50 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 101.20	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
SEFARIX 125mg/5ml Powder For Suspension	25 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 41.85	Generic · Prescription	Pharma International Co.	Valid
SEFARIX 125mg/5ml Powder For Suspension	25 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 65.30	Generic · Prescription	Pharma International Co.	Valid
SEFARIX 300 mg Capsule	300 mg	Capsule · Oral use	10 Bottle	SAR 57.80	Generic · Prescription	Pharma International Co.	Valid
Sefarix	300 mg	Capsule · Oral use	20 Bottle	SAR 104.00	Generic · Prescription	PHARMA INTERNATIONAL CO	Valid
XEVANEER 125mg/5ml Powder For Oral Suspension	25 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 29.80	Generic · Prescription	DAR ALDAWA	Valid
XEVANEER 125mg/5ml Powder For Oral Suspension	25 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 59.60	Generic · Prescription	DAR ALDAWA	Valid
Xevaneer 300 mg capsule	300 mg	Capsule · Oral use	10 Bottle	SAR 52.00	Generic · Prescription	DAR ALDAWA	Valid

Indications — CHI Daman Drug Formulary

BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; INTRA-ABDOMINAL INFECTIONS; OSTEOMYELITIS; OTITIS MEDIA; TRAVEL RELATED INFECTIONS-TREATMENT

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

Product	Strength	Form · route	Applicant	Status	First approved
CEFDINIR	300MG	capsule · oral	LUPIN	Prescription	19 May 2006
CEFDINIR	125MG/5ML; 250MG/5ML	for suspension · oral	LUPIN	Prescription	31 May 2006
CEFDINIR	300MG	capsule · oral	CHARTWELL RX	Prescription	6 Apr 2007
CEFDINIR	125MG/5ML; 250MG/5ML	for suspension · oral	CHARTWELL RX	Prescription	6 Apr 2007
CEFDINIR	125MG/5ML; 250MG/5ML	for suspension · oral	TEVA PHARMS	Prescription	4 May 2007
CEFDINIR	300MG	capsule · oral	TEVA PHARMS	Prescription	9 May 2007
CEFDINIR	300MG	capsule · oral	ANDA REPOSITORY	Prescription	18 Jul 2007
CEFDINIR	125MG/5ML; 250MG/5ML	for suspension · oral	ANDA REPOSITORY	Prescription	18 Jul 2007
CEFDINIR	125MG/5ML; 250MG/5ML	for suspension · oral	AUROBINDO PHARMA	Prescription	14 Dec 2007
CEFDINIR	300MG	capsule · oral	AUROBINDO PHARMA	Prescription	7 Jan 2008
CEFDINIR	300MG	capsule · oral	ALKEM LABS LTD	Prescription	19 Feb 2021
CEFDINIR	125MG/5ML; 250MG/5ML	for suspension · oral	ALKEM LABS LTD	Prescription	19 Feb 2021
OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	ABBVIE	Discontinued	4 Dec 1997
OMNICEF	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	ABBVIE	Discontinued	4 Dec 1997

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CEFDINIR 125 MG/5 ML SUSP	$0.11131	per ML	23 Sep 2026
US NADAC	CEFDINIR 125 MG/5 ML SUSP	$0.10536	per ML	23 Sep 2026
US NADAC	CEFDINIR 250 MG/5 ML SUSP	$0.11757	per ML	23 Sep 2026
US NADAC	CEFDINIR 250 MG/5 ML SUSP	$0.10999	per ML	23 Sep 2026
US NADAC	CEFDINIR 300 MG CAPSULE	$0.45808	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.