ACETYLCYSTEINE SOLUTION USP 200 MG — DIN 02459906
ACETYLCYSTEINE : 200 MG · HIKMA CANADA LIMITED · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is ACETYLCYSTEINE SOLUTION USP?
ACETYLCYSTEINE SOLUTION USP 200 MG contains ACETYLCYSTEINE : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02459906, held by HIKMA CANADA LIMITED, supplied as SOLUTION for INTRAVENOUS ; INHALATION ; ORAL administration. Health Canada currently lists it as marketed, status dated 13-Jun-2023. 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 ACETYLCYSTEINE SOLUTION USP used for?
Acetylcysteine Solution USP (Acetylcysteine 200 mg/mL) is indicated as adjuvant therapy for patients with abnormal, viscid or inspissated mucous secretions in such conditions as chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis, and primary amyloidosis of the lung); acute bronchopulmonary disease (pneumonia, bronchitis and tracheobronchitis); pulmonary complications of cystic fibrosis; post tracheostomy care, pulmonary complications associated with surgery; use during anesthesia; post-traumatic chest conditions; atelectasis due to mucous obstruction; diagnostic bronchial studies (bronchograms, bronchospirometry and bronchial wedge catheterization). Acetylcysteine Solution USP administered orally or intravenously is also indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Acetylcysteine cost around the world?
Acetylcysteine is listed on 11 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max); Czechia publishes a max producer price (ex-factory). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| South Africa | single exit price | 19 | 27 | ZAR███.██ |
| United States | acquisition | 2 | 18 | USD███.██ |
| Luxembourg | reimbursement | 17 | 17 | EUR███.██ |
| United Arab Emirates | public | 5 | 6 | AED███.██ |
| Austria | KVP (Kassenverkaufspreis) | 6 | 6 | EUR███.██ |
| Saudi Arabia | public | 6 | 6 | SAR███.██ |
| United Kingdom | hospital | 3 | 3 | GBP███.██ |
| Bahrain | retail (max) | 2 | 2 | BHD███.██ |
| Czechia | max producer price (ex-factory) | 2 | 2 | CZK███.██ |
| Morocco | PPV (public price) | 2 | 2 | MAD███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
90 pack listings across 65 brand entries and 10 price bases, refreshed 05 Sep 2026. Ranges span every Acetylcysteine pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Acetylcysteine 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.
10 holders have a Canadian DIN containing Acetylcysteine, across 10 DINs, of which 3 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 |
|---|---|---|---|---|
| HIKMA CANADA LIMITED | 1 | 1 | ACETYLCYSTEINE SOLUTION USP | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | ACETYLCYSTEINE SOLUTION | Sourceable in Canada |
| STERIMAX INC | 1 | 1 | ACETYLCYSTEINE SOLUTION USP | Sourceable in Canada |
| AURO PHARMA INC | 1 | 0 | ACETYLCYSTEINE INJECTION | No marketed DIN |
| BIONICHE PHARMA (CANADA) LTD | 1 | 0 | PARVOLEX LIQ IV 200MG/ML | No marketed DIN |
| BRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBB | 1 | 0 | MUCOMYST INJ 200MG/ML | No marketed DIN |
| EUGIA PHARMA INC. | 1 | 0 | ACETYLCYSTEINE INJECTION | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 1 | 0 | PARVOLEX | No marketed DIN |
| TELIGENT OU | 1 | 0 | ACETYLCYSTEINE INJECTION | No marketed DIN |
| WELLSPRING PHARMACEUTICAL CANADA CORP | 1 | 0 | MUCOMYST | 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 | 200 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS ; INHALATION ; ORAL |
| Storage | If only a portion of the solution in the vial is used, the remainder should be stored in a refrigerator and used within 96 hours to minimize contamination. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Acetylcysteine |
|---|---|
| ATC code | R05CB01 |
| AHFS class | 91:04.04 |
| 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) | 02459906 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2459906 |
| Brand name | ACETYLCYSTEINE SOLUTION USP |
| Generic / active ingredient | ACETYLCYSTEINE : 200 MG |
| Market authorization holder | HIKMA CANADA LIMITED |
| Health Canada schedule | Ethical |
| ATC code | R05CB01 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R05CB |
| Current status | MARKETED |
| Status date | 13-Jun-2023 |
| Original market date | 2018-01-26 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
Is Acetylcysteine in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Active — reported by SANDOZ CANADA INCORPORATED, last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
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
3 of 10 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACETYLCYSTEINE SOLUTION | 200 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02243098 |
| ACETYLCYSTEINE SOLUTION USP | 200 MG | SOLUTION | STERIMAX INC | MARKETED | 02538431 |
| ACETYLCYSTEINE INJECTION | 200 MG | SOLUTION | TELIGENT OU | CANCELLED POST MARKET | 02300435 |
| ACETYLCYSTEINE INJECTION | 200 MG | SOLUTION | AURO PHARMA INC | APPROVED | 02528274 |
| ACETYLCYSTEINE INJECTION | 200 MG | SOLUTION | EUGIA PHARMA INC. | APPROVED | 02534908 |
| MUCOMYST | 200 MG | SOLUTION | WELLSPRING PHARMACEUTICAL CANADA CORP | CANCELLED POST MARKET | 02091526 |
| MUCOMYST INJ 200MG/ML | 200 MG | LIQUID | BRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBB | CANCELLED POST MARKET | 00606235 |
| PARVOLEX | 200 MG | LIQUID | MYLAN PHARMACEUTICALS ULC | CANCELLED POST MARKET | 02181460 |
| PARVOLEX LIQ IV 200MG/ML | 200 MG | LIQUID | BIONICHE PHARMA (CANADA) LTD | CANCELLED POST MARKET | 02094738 |
2 · Same class — other molecules in ATC R05CB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Acetylcysteine | ACETYLCYSTEINE INJECTION · ACETYLCYSTEINE SOLUTION · ACETYLCYSTEINE SOLUTION USP · MUCOMYST · +3 more | 10 | 3 | Yes |
| Dornase Alfa (Desoxyribonuclease) | PULMOZYME | 1 | 1 | Yes |
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 R05C
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R05CA | Combinations · Guaifenesin | 101 | 14 |
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.
What else is ACETYLCYSTEINE SOLUTION USP called?
The same molecule, Acetylcysteine, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Tussmuco | Latin | South Africa |
| Mucolator | Latin | Morocco, South Africa |
| ACC ® Long | Latin | United Arab Emirates |
| ACC INJEKT | Latin | Czechia |
| ACC LONG | Latin | Bahrain |
| Acetylcysteine | Latin | Iceland |
| FLUIMUCIL | Latin | Morocco |
| Mucotrin | Latin | South Africa |
| NAC AL | Latin | Czechia |
| Paradote | Latin | South Africa |
| Trinflem | Latin | South Africa |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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.
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.