Is Caffeine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Caffeine, including BIOCAFFCIT (10 mg/ml, Solution for injection, SAR 398.95); BIOCAFFCIT (20 mg, Solution for injection, SAR 2393.65); BIOCAFFCIT (20 mg/ml, Oral solution, SAR 2393.65); Biocaffcit (20 mg/ml, Solution for injection, SAR 699.00); CAFFEINE CITRATE 10 mg/ml Solution For Injection (10 mg/ml, Solution for injection, SAR 415.00).

Is Caffeine approved by the US FDA?

Drugs@FDA lists 15 application product lines for Caffeine, including CAFCIT (Prescription); CAFFEINE CITRATE (Prescription); CAFFEINE CITRATE (Prescription); CAFFEINE CITRATE (Prescription); CAFFEINE CITRATE (Prescription).

Is Caffeine authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Caffeine: Peyona (previously Nymusa), Gencebok.

Is Caffeine on the WHO Model List of Essential Medicines?

Yes — 22.7. Medicines administered to the neonate [c] (core list): Apnoea of newborn.

Are there safety signals or safety updates for Caffeine?

US FDA: 8 entries; MHRA: 1 entry (latest 2025-12-22).

Active substance

Caffeine

SFDA 9
US FDA 15
EMA 3
Health Canada 3
US price lines 1
NHS prices 1
WHO EML 1
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BIOCAFFCIT	10 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 398.95	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
BIOCAFFCIT	10 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 797.90	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
BIOCAFFCIT	20 mg	Solution for injection · Intravenous use	10 Vial	SAR 2393.65	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
BIOCAFFCIT	20 mg/ml	Oral solution · Oral use	10 Vial	SAR 2393.65	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
Biocaffcit	20 mg/ml	Solution for injection · Intravenous, Oral	10 Vial	SAR 699.00	Generic · Prescription	Pharmaceutical Solutions Industry Ltd	Valid
CAFFEINE CITRATE 10 mg/ml Solution For Injection	10 mg/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 415.00	NCE · Prescription	Martindale Pharma	Valid
Caffate	20 mg/ml	Solution for infusion and oral solution · Intravenous, Oral	10 Vial	SAR 2247.90	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Gencebok	10 mg/ml	Solution for infusion · Intravenous, Oral	10 Ampoule	SAR 374.65	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
PEYONA 20MG/ML SOL. FOR INF. AND ORAL Solution	20 mg/ml	Solution for infusion and oral solution · Intravenous, Oral	10 Bottle	SAR 699.00	NCE · Prescription	CHIESI FARMACEUTICIS	Valid

Indications — CHI Daman Drug Formulary

NEONATAL RESPIRATORY DISTRESS SYNDROME (NRDS)

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

Product	Strength	Form · route	Applicant	Status	First approved
CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · intravenous	HIKMA PHARMS	Prescription	21 Sep 1999
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · intravenous	EXELA PHARMA SCIENCE	Prescription	21 Sep 2006
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · oral	EXELA PHARMA	Prescription	21 Sep 2006
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · intravenous	AM REGENT	Prescription	15 May 2007
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · intravenous	FRESENIUS KABI USA	Prescription	20 Jul 2007
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · oral	FRESENIUS KABI USA	Prescription	31 Jan 2008
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · intravenous	SAGENT PHARMS	Prescription	29 Aug 2012
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · oral	SAGENT PHARMS	Prescription	29 Aug 2012
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · intravenous	MICRO LABS	Prescription	14 Dec 2017
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · oral	MICRO LABS	Prescription	16 Dec 2019
CAFCIT	EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral	HIKMA PHARMS	Discontinued	21 Sep 1999
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · intravenous	SUN PHARM	Discontinued	30 Sep 2009
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · oral	SUN PHARM	Discontinued	30 Sep 2009
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · oral	AM REGENT	Discontinued	20 Nov 2009
CAFFEINE CITRATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	solution · intravenous	EUGIA PHARMA	Discontinued	22 Sep 2015

EMA European Union — centrally authorised medicines

Peyona (previously Nymusa) Chiesi Farmaceutici SpA · Authorised · authorised 2 Jul 2009 · ATC N06BC01

Therapeutic indication (EMA)

Treatment of primary apnoea of premature newborns.

Gencebok Gennisium Pharma · Authorised · authorised 19 Aug 2020 · ATC N06BC01

Therapeutic indication (EMA)

Treatment of primary apnoea of premature newborns.

Blectifor Viridian Pharma Ltd · Application withdrawn

Therapeutic indication (EMA)

Indicated in preterm neonates for the prevention of bronchopulmonary dysplasia

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CAFFEINE CITRATE INJECTION USP	02526778	20 MG / ML	SOLUTION · INTRAVENOUS	OMEGA LABORATORIES LIMITED
CAFFEINE CITRATE ORAL SOLUTION USP	02526751	20 MG / ML	SOLUTION · ORAL	OMEGA LABORATORIES LIMITED
PEYONA	02496771	20 MG / ML	SOLUTION · INTRAVENOUS; ORAL	CHIESI FARMACEUTICI S.P.A.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CAFFEINE 200 MG TABLET	$0.08299	per EA	23 Sep 2026
NHS Drug Tariff	Caffeine citrate 50mg/5ml oral solution	£25.99	5 ml	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)

22.7. Medicines administered to the neonate [c] · core
Apnoea of newborn
Parenteral > General injections > IV: 20 mg per mL (equivalent to 10 mg caffeine base per mL) (EMLc) | Oral > Liquid: 20 mg per mL (equivalent to 10 mg caffeine base per mL) (EMLc)

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 FIORICET W/ CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2025 SYNALGOS-DC — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 3 Nov 2021 EXCEDRIN (MIGRAINE) — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 28 Apr 2021 FIORINAL W/CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Apr 2021 FIORINAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Apr 2021 NORGESIC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Apr 2021 NORGESIC FORTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Mar 2020 CAFCIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
MHRA 11 Dec 2014 Caffeine citrate: 2 products of different strengths now available
Care must be taken with dosing as the 2 products are not equivalent.

All safety entries for caffeine →

Combinations containing Caffeine

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.