PMS-SODIUM CROMOGLYCATE 1 % — DIN 02046113
CROMOLYN SODIUM : 1 % · PHARMASCIENCE INC · SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is PMS-SODIUM CROMOGLYCATE?
PMS-SODIUM CROMOGLYCATE 1 % contains CROMOLYN SODIUM : 1 %. It is listed in the Health Canada Drug Product Database under DIN 02046113, held by PHARMASCIENCE INC, supplied as SOLUTION for INHALATION administration. Health Canada currently lists it as cancelled post market, status dated 31-Mar-2023. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is PMS-SODIUM CROMOGLYCATE used for?
pms-SODIUM CROMOGLYCATE nebulizer solution is indicated as an adjunct in the management of intrinsic and extrinsic asthma, including exercise-induced asthma, cold air-induced asthma and occupational asthma and are used on a continuous basis to prevent symptoms of these conditions.
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 Cromoglicic Acid 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.
7 holders have a Canadian DIN containing Cromoglicic Acid, across 9 DINs, of which 0 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 |
|---|---|---|---|---|
| AVENTIS PHARMA INC | 3 | 0 | INTAL NEBULIZER 1%, INTAL SPINCAPS 20MG, INTAL SYNCRONER | No marketed DIN |
| APOTEX INC | 1 | 0 | APO-CROMOLYN STERULES | No marketed DIN |
| GENPHARM ULC | 1 | 0 | GEN-CROMOGLYCATE STERINEBS - LIQ INH 1% | No marketed DIN |
| NOVOPHARM LIMITED | 1 | 0 | NOVO-CROMOLYN NEBULIZER SOLUTION 1% | No marketed DIN |
| NU-PHARM INC | 1 | 0 | NU-CROMOLYN PLASTIC AMPULES | No marketed DIN |
| PHARMASCIENCE INC | 1 | 0 | PMS-SODIUM CROMOGLYCATE | No marketed DIN |
| SANOFI-AVENTIS CANADA INC | 1 | 0 | INTAL INHALER | 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 | 1 % |
|---|---|
| Dosage form | SOLUTION |
| Route | INHALATION |
| Pack configuration (monograph) | Available in cartons of 50. Each polyneb contains 2 mL of a sterile 1% cromolyn sodium solution in water. Also: Cartons containing 50 X 2 mL Polynebs. |
| Storage | Store between 15°C and 30°C. Do not refrigerate. Protect from direct sunlight. Discard any unused polynebs in opened foil packs after 3 months. Do not use the solution if it contains a precipitate. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Cromoglicic Acid |
|---|---|
| ATC code | R03BC01 |
| AHFS class | 48:10.32 |
| 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) | 02046113 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2046113 |
| Brand name | PMS-SODIUM CROMOGLYCATE |
| Generic / active ingredient | CROMOLYN SODIUM : 1 % |
| Market authorization holder | PHARMASCIENCE INC |
| Health Canada schedule | Prescription |
| ATC code | R03BC01 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R03BC |
| Current status | CANCELLED POST MARKET |
| Status date | 31-Mar-2023 |
| Original market date | 1993-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
0 of 9 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-CROMOLYN STERULES | 1 % | SOLUTION | APOTEX INC | CANCELLED POST MARKET | 02231431 |
| GEN-CROMOGLYCATE STERINEBS - LIQ INH 1% | 1 % | LIQUID | GENPHARM ULC | CANCELLED POST MARKET | 02219468 |
| INTAL INHALER | 1 MG | METERED-DOSE AEROSOL | SANOFI-AVENTIS CANADA INC | CANCELLED POST MARKET | 00555649 |
| INTAL NEBULIZER 1% | 1 % | SOLUTION | AVENTIS PHARMA INC | CANCELLED POST MARKET | 00534609 |
| INTAL SPINCAPS 20MG | 20 MG | POWDER | AVENTIS PHARMA INC | CANCELLED POST MARKET | 00261238 |
| INTAL SYNCRONER | 1 MG | METERED-DOSE AEROSOL | AVENTIS PHARMA INC | CANCELLED POST MARKET | 00638641 |
| NOVO-CROMOLYN NEBULIZER SOLUTION 1% | 1 % | SOLUTION | NOVOPHARM LIMITED | CANCELLED POST MARKET | 02049082 |
| NU-CROMOLYN PLASTIC AMPULES | 10 MG | SOLUTION | NU-PHARM INC | CANCELLED POST MARKET | 02231671 |
2 · Same class — other molecules in ATC R03BC
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Cromoglicic Acid | APO-CROMOLYN STERULES · GEN-CROMOGLYCATE STERINEBS - LIQ INH 1% · INTAL INHALER · INTAL NEBULIZER 1% · +5 more | 9 | 0 | Not in Canada |
| Nedocromil | TILADE · TILADE INHALER 2MG/AEM | 2 | 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 R03B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R03BA | Beclometasone · Budesonide · Ciclesonide · Flunisolide · Fluticasone · +3 more | 66 | 33 |
| R03BB | Aclidinium Bromide · Glycopyrronium Bromide · Ipratropium Bromide · Tiotropium Bromide · Umeclidinium Bromide | 37 | 15 |
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 PMS-SODIUM CROMOGLYCATE called?
Also recorded in Canada as: cromolyn sodium 5.2 MG/ACTUAT Metered Dose Nasal Spray [Nasalcrom] (US), cromolyn sodium 20 MG/ML Oral Solution [Gastrocrom] (US), cromolyn sodium 5.2 MG/ACTUAT Metered Dose Nasal Spray (US), cromolyn sodium 20 MG Inhalation Powder (US), cromolyn sodium 20 MG/ML Ophthalmic Solution (US), cromolyn sodium 20 MG/ML / xylometazoline 0.25 MG/ML Nasal Spray (US), cromolyn sodium 40 MG/ML Ophthalmic Solution (US), cromolyn sodium 10 MG/ML Inhalation Solution (US), cromolyn sodium 20 MG/ML Oral Solution (US), cromolyn sodium 100 MG Oral Capsule (US), cromolyn sodium 5.2 MG/ACTUAT Nasal Spray (US), CROMOLYN SODIUM (US), CROMOLYN SODIUM INHALATION SOLUTION (US), CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) (US).
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.