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Fentanyl

Sold as Durogesic /h, Pharma-q fentanyl, Tenyl /h, Fentanyl sandoz /h, Fendermal /h, Effentora, Fentanyl acino, Sublimaze, Fentanyl fresenius, Fetanyl fresenius

S6Read from the PI-PIL document and verified
Loading the molecular structure
C22H28N2O336.50 g/mol

N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide

Drag to rotate. Structure from PubChem CID 3345.

Background

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Registration

Applicants
8
Registrations
33
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Janssen Pharmaceutica (Pty) LtdDurogesic /h12 ug, 25 ug, 50 ug, 75 ug, 100 ug280288, 280289, 280290, 280291, A400203Not determinedNone
Pharma-q Holdings (Pty) LtdPharma-q fentanyl100 ug/2 ml, 500 ug/10 ml290604, 290605Not determinedNone
Mc Pharma (Pty) LtdTenyl /h25 ug, 50 ug, 75 ug, 100 ug410255, 410256, 410257, 410258Not determinedNone
Sandoz South Africa (Pty) Ltd4 of 8 cancelledFentanyl sandoz /h, Fendermal /h25 ug, 50 ug, 75 ug, 100 ug440753, 440754, 440755, 440756, 440757, 440758, 440759, 440760Not determinedNone
Teva Pharmaceuticals (Pty) LtdEffentora100, 200, 400, 600, 800480054, 480055, 480056, 480057, 480058Not determinedPIPIL
Acino Pharma (Pty) LtdCancelledFentanyl acino12, 25, 50, 75, 100500404, 500405, 500406, 500407, 500408Not determinedNone
Piramal Critical Care South Africa (Pty) LtdSublimaze2ml/10 mlB1014, Q0034S6PIPIL
Fresenius Kabi Manufacturing SA (Pty) LtdFentanyl fresenius, Fetanyl fresenius100 mcg/2 ml, 500 mcg/10 mlW0123, X0260Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Durogesic 25 ug/h

EACH PATCH CONTAINS FENTANYL 2,5 mg

25 ug28028828/2.9/0288RegisteredNot determinedNone
Durogesic 50 ug/h

EACH PATCH CONTAINS FENTANYL 5,0 mg

50 ug28028928/2.9/0289RegisteredNot determinedNone
Durogesic 75 ug/h

EACH PATCH CONTAINS FENTANYL 7,5 mg

75 ug28029028/2.9/0290RegisteredNot determinedNone
Durogesic 100 ug/h

EACH PATCH CONTAINS FENTANYL 10,0 mg

100 ug28029128/2.9/0291RegisteredNot determinedNone
Pharma-q fentanyl 500 ug/10 ML injection

EACH 10 ml SOLUTION CONTAINS FENTANYL CITRATE EQUIVALENT TO 500 ug FENTANYL

500 ug/10 mlInjection29060429/2.7/0604RegisteredNot determinedNone
Pharma-q fentanyl 100 ug/2 ML injection

EACH 2 ml SOLUTION CONTAINS FENTANYL CITRATE EQUIVALENT TO 100 ug FENTANYL

100 ug/2 mlInjection29060529/2.7/0605RegisteredNot determinedNone
Tenyl 25 ug/h

EACH PATCH CONTAINS FENTANYL 4,8 g

25 ug41025541/2.11/0255RegisteredNot determinedNone
Tenyl 50 ug/h

EACH PATCH CONTAINS FENTANYL 9,6 g

50 ug41025641/2.11/0256RegisteredNot determinedNone
Tenyl 75 ug/h

EACH PATCH CONTAINS FENTANYL 14,4 g

75 ug41025741/2.11/0257RegisteredNot determinedNone
Tenyl 100 ug/h

EACH PATCH CONTAINS FENTANYL 19,2 g

100 ug41025841/2.11/0258RegisteredNot determinedNone
Fentanyl sandoz 25 ug/h

EACH PATCH CONTAINS: FENTANYL 25,0 ug/h

25 ug44075344/2.9/0753CancelledNot determinedNone
Fentanyl sandoz 50 ug/h

EACH PATCH DELIVERS: FENTANYL 50,0 ug/h

50 ug44075444/2.9/0754CancelledNot determinedNone
Fentanyl sandoz 75 ug/h

EACH PATCH DELIVERS: FENTANYL 75,0 ug/h

75 ug44075544/2.9/0755CancelledNot determinedNone
Fentanyl sandoz 100 ug/h

EACH PATCH DELIVERS: FENTANYL 100,0 ug/h

100 ug44075644/2.9/0756CancelledNot determinedNone
Fendermal 25 ug/h

EACH PATCH DELIVERS FENTANYL 25,0 ug

25 ug44075744/2.9/0757RegisteredNot determinedNone
Fendermal 50 ug/h

EACH PATCH DELIVERS FENTANYL 50,0 ug

50 ug44075844/2.9/0758RegisteredNot determinedNone
Fendermal 75 ug/h

EACH PATCH DELIVERS FENTANYL 75,0 ug

75 ug44075944/2.9/0759RegisteredNot determinedNone
Fendermal 100 ug/h

EACH PATCH DELIVERS FENTANYL 100,0 ug

100 ug44076044/2.9/0760RegisteredNot determinedNone
Effentora 100100Effervescent buccal tablets.48005448/2.9/0054Approved 18 February 2025RegisteredNot determinedPIPIL
Effentora 200200Effervescent buccal tablets.48005548/2.9/0055Approved 18 February 2025RegisteredNot determinedPIPIL
Effentora 400400Effervescent buccal tablets.48005648/2.9/0056Approved 18 February 2025RegisteredNot determinedPIPIL
Effentora 600600Effervescent buccal tablets.48005748/2.9/0057Approved 18 February 2025RegisteredNot determinedPIPIL
Effentora 800800Effervescent buccal tablets.48005848/2.9/0058Approved 18 February 2025RegisteredNot determinedPIPIL
Fentanyl 12 acino

Each Transdermal Patch contains: Fentanyl 2,55 mg

1250040450/2.9/0404CancelledNot determinedNone
Fentanyl 25 acino

Each Transdermal Patch contains: Fentanyl 25 mg

2550040550/2.9/0405CancelledNot determinedNone
Fentanyl 50 acino

Each Transdermal Patch contains: Fentanyl 50 mg

5050040650/2.9/0406CancelledNot determinedNone
Fentanyl 75 acino

Each Transdermal Patch contains: Fentanyl 75 mg

7550040750/2.9/0407CancelledNot determinedNone
Fentanyl 100 acino

Each Transdermal Patch contains: Fentanyl 100 mg

10050040850/2.9/0408CancelledNot determinedNone
Durogesic 12 ug/h

EACH PATCH CONTAINS FENTANYL 2,1 mg

12 ugA400203A40/2.9/0203RegisteredNot determinedNone
Sublimaze 2 ML

1 ML FENTANYL CITRATE 0,0785 MG

2ml/10 mlInjectionB1014B/2.9/1014Approved 24 July 2025RegisteredS6PIPIL
Sublimaze 10 ML

EACH 1 ml CONTAINS FENTANYL CITRATE 0,0785 Mg EQUIVALENT TO 0,05MG FENTANYL BASE

2ml/10 mlInjectionQ0034Q/2.9/0034Approved 24 July 2025RegisteredS6PIPIL
Fentanyl 100 mcg/2 ML fresenius

EACH 2,0 ml AMPOULE CONTAINS FENTANYL CITRATE EQUIVALENT TO 100,0 ug FENTANYL BASE

100 mcg/2 mlW0123W/2.9/123RegisteredNot determinedNone
Fetanyl 500 mcg/10 ML fresenius

EACH 10 ml CONTAINS FENTANYL CITRATE EQUIVALENT TO 500 ug FENTANYL BASE

500 mcg/10 mlX0260X/2.7/260RegisteredNot determinedNone

Regulatory status

Where S6 sits on the scale

Prescription-only, no repeats without a new prescription.

Schedule 6 covers the most tightly controlled ordinary prescription medicines. Every dispensing needs its own new prescription; nothing can be repeated on the same script. When prescribed, the quantity must be written out in both figures and words. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S6, read from the product's PI-PIL leaflet.

The Consolidated Schedules list this ingredient up to S7; the leaflet's S6 applies to this product.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.

Consolidated Schedules listings for Fentanyl citrate

  • S6: Fentanyl

    • when intended for therapeutic purposes.

    Consolidated Schedules 06 July 2026, line 10256

Pharmacological class: Other analgesics. (class 2.9)

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

Professional information (PI)For healthcare professionalsEffentora 100, Teva Pharmaceuticals (Pty) LtdPatient information leaflet (PIL)For patients and carersEffentora 100, Teva Pharmaceuticals (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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