APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 15 MG — DIN 02554615
CODEINE PHOSPHATE : 15 MG CAFFEINE : 40 MG ACETYLSALICYLIC ACID : 330 MG BUTALBITAL : 50 MG · APOTEX INC · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4?
APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 15 MG contains CODEINE PHOSPHATE : 15 MG CAFFEINE : 40 MG ACETYLSALICYLIC ACID : 330 MG BUTALBITAL : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02554615, held by APOTEX INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 08-May-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 used for?
Indicated for the relief of tension-type headache in adults.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Codein, Combinations With Psycholeptics in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
8 holders have a Canadian DIN containing Codein, Combinations With Psycholeptics, across 17 DINs, of which 6 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| APOTEX INC | 2 | 2 | APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/2, APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 | Sourceable in Canada |
| ARALEZ PHARMACEUTICALS CANADA INC | 2 | 2 | FIORINAL-C 1/2, FIORINAL-C 1/4 | Sourceable in Canada |
| TEVA CANADA LIMITED | 2 | 2 | TEVA-TECNAL C 1/2, TEVA-TECNAL C 1/4 | Sourceable in Canada |
| AYERST LABORATORIES | 3 | 0 | PHENAPHEN NO 2 CAP, PHENAPHEN NO 3 CAP, PHENAPHEN NO 4 CAP | No marketed DIN |
| WYETH-AYERST CANADA INC. | 3 | 0 | PHENAPHEN NO.2 CAP, PHENAPHEN NO.3 CAP, PHENAPHEN NO.4 CAP | No marketed DIN |
| LABORATOIRE RIVA INC. | 2 | 0 | TRIANAL C½, TRIANAL C¼ | No marketed DIN |
| PRO DOC LIMITEE | 2 | 0 | PRONAL - C1/2 CAPSULES, PRONAL C1/4 CAPSULES | No marketed DIN |
| PHARMASCIENCE INC | 1 | 0 | PMS-PHARNAL-C1/2 CAPSULES | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 15 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in provided text (refers to DOSAGE FORMS, COMPOSITION AND PACKAGING section). |
| Storage | Not explicitly detailed in provided text (refers to STORAGE AND STABILITY section). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Codein, Combinations With Psycholeptics |
|---|---|
| ATC code | N02AA79 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02554615 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2554615 |
| Brand name | APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 |
| Generic / active ingredient | CODEINE PHOSPHATE : 15 MG CAFFEINE : 40 MG ACETYLSALICYLIC ACID : 330 MG BUTALBITAL : 50 MG |
| Market authorization holder | APOTEX INC |
| Health Canada schedule | NARCOTICS (CDSA I) |
| ATC code | N02AA79 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N02AA |
| Current status | MARKETED |
| Status date | 08-May-2025 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Capsules must be swallowed whole. Dosage should be the lowest effective dose for the shortest duration. Not recommended for patients under 18 years of age.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to ASA, caffeine, codeine, or butalbital; GI obstruction; asthma; respiratory depression; pregnancy/breast-feeding; children <18 for tonsillectomy; CYP2D6 ultra-rapid metabolizers.
Warnings and precautions
Risk of addiction, abuse, misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; risks with benzodiazepines/alcohol; ASA-related bleeding/Reye's syndrome.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
6 of 17 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/2 | 50 MG | CAPSULE | APOTEX INC | MARKETED | 02554623 |
| FIORINAL-C 1/2 | 330 MG | CAPSULE | ARALEZ PHARMACEUTICALS CANADA INC | MARKETED | 00176206 |
| FIORINAL-C 1/4 | 40 MG | CAPSULE | ARALEZ PHARMACEUTICALS CANADA INC | MARKETED | 00176192 |
| TEVA-TECNAL C 1/2 | 40 MG | CAPSULE | TEVA CANADA LIMITED | MARKETED | 00608181 |
| TEVA-TECNAL C 1/4 | 40 MG | CAPSULE | TEVA CANADA LIMITED | MARKETED | 00608203 |
| PHENAPHEN NO 2 CAP | 16.2 MG | CAPSULE | AYERST LABORATORIES | CANCELLED POST MARKET | 01909290 |
| PHENAPHEN NO 3 CAP | 16.2 MG | CAPSULE | AYERST LABORATORIES | CANCELLED POST MARKET | 01909312 |
| PHENAPHEN NO 4 CAP | 64.8 MG | CAPSULE | AYERST LABORATORIES | CANCELLED POST MARKET | 01909304 |
| PHENAPHEN NO.2 CAP | 16.2 MG | CAPSULE | WYETH-AYERST CANADA INC. | CANCELLED POST MARKET | 02042851 |
| PHENAPHEN NO.3 CAP | 325 MG | CAPSULE | WYETH-AYERST CANADA INC. | CANCELLED POST MARKET | 02042878 |
2 · Same class — other molecules in ATC N02AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Morphine | BAR-MORPHINE SR · DOLORAL SIROP · KADIAN · M-EDIAT · +86 more | 172 | 56 | Yes |
| Hydromorphone | APO-HYDROMORPHONE · APO-HYDROMORPHONE CR · BAR-HYDROMORPHONE CR · DILAUDID · +40 more | 85 | 34 | Yes |
| Oxycodone | ACT OXYCODONE CR · APO-OXYCODONE CR · OXY.IR · OXYCODONE · +16 more | 68 | 28 | Yes |
| Codein, Combinations With Psycholeptics | APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/2 · APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4 · FIORINAL-C 1/2 · FIORINAL-C 1/4 · +13 more | 17 | 6 | Yes |
| Oxycodone And Naloxone | TARGIN | 4 | 4 | Yes |
| Codeine, Combinations Excl. Psycholeptics | AXACET-C1/8 · AXISAL-C1/8 · METHOXACET-C 1/8 · METHOXISAL-C 1/2 · +21 more | 25 | 1 | Yes |
| Natural Opium Alkaloids | NUMORPHAN INJECTION 1.5MG/ML · NUMORPHAN SUPPOSITORY 5MG · OPANA ER | 6 | 0 | Not in Canada |
| Opium | OPIUM TEINTURE | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC N02A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N02AX | Tapentadol · Tramadol | 41 | 30 |
| N02AJ | Codeine And Acetylsalicylic Acid · Codeine And Paracetamol · Hydrocodone And Ibuprofen · Oxycodone And Acetylsalicylic Acid · Oxycodone And Paracetamol · +1 more | 137 | 21 |
| N02AB | Fentanyl · Pethidine | 105 | 17 |
| N02AE | Buprenorphine | 15 | 4 |
| N02AF | Butorphanol · Nalbufine | 5 | 2 |
| N02AG | Opioids In Comb With Antispasmodics | 3 | 0 |
| N02AD | Pentazocine | 3 | 0 |
| N02AC | Dextropropoxyphene · Dextropropoxyphene, Comb Excl Psycholept | 7 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Request a quote for APO-BUTALBITAL-ACETYLSALICYLIC ACID-CAFFEINE-CODEINE-C 1/4
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.