Nexara Health — Health Canada Drug Establishment Licence #3-002896

SANDOZ SITAGLIPTIN-METFORMIN XR 50 MG

Last verified 2026-09-08 · Source: Health Canada Drug Product Database (DPD), DIN 02529106

SANDOZ SITAGLIPTIN-METFORMIN XR 50 MG

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) : 50 MG METFORMIN HYDROCHLORIDE : 500 MG · DIN 02529106 · SANDOZ CANADA INCORPORATED

Health Canada status: MARKETED

What is SANDOZ SITAGLIPTIN-METFORMIN XR?

SANDOZ SITAGLIPTIN-METFORMIN XR 50 MG contains SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) : 50 MG METFORMIN HYDROCHLORIDE : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 02529106, held by SANDOZ CANADA INCORPORATED, supplied as TABLET (EXTENDED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 22-Mar-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 SANDOZ SITAGLIPTIN-METFORMIN XR used for?

Sandoz Sitagliptin - Metformin XR (sitagliptin/metformin hydrochloride modified-release) are indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus inadequately controlled on metformin or in patients already being treated with the combination of sitagliptin and metformin. Add-on combination: Sandoz Sitagliptin - Metformin XR is indicated for use as a triple combination therapy in adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with: sulfonylurea, premixed or long/intermediate acting insulin, or pioglitazone when the existing dual therapy with metformin, along with diet and exercise, does not provide adequate glycemic control.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

DIN02529106
Brand nameSANDOZ SITAGLIPTIN-METFORMIN XR
Generic / active ingredientSITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) : 50 MG METFORMIN HYDROCHLORIDE : 500 MG
ManufacturerSANDOZ CANADA INCORPORATED
Strength50 MG
Dosage formTABLET (EXTENDED-RELEASE)
Route of administrationORAL
SchedulePrescription
ATC codeA10BD07 METFORMIN AND SITAGLIPTIN
AHFS class90:24.24.92
BiosimilarNo
Health Canada statusMARKETED
Status date22-Mar-2023
Original market date2024-01-30 00:00:00

How is it administered?

Individualize dose. Max daily dose: 100 mg sitagliptin/2000 mg metformin. Take once daily with a meal, preferably in the evening. Tablets must be swallowed whole; do not split, crush, or chew.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

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How is it supplied?

Sandoz Sitagliptin - Metformin XR Tablets, 50 mg/500 mg: bottles of 60 and 360. Sandoz Sitagliptin - Metformin XR Tablets, 50 mg/1000 mg: bottles of 60 and 260. Sandoz Sitagliptin - Metformin XR Tablets, 100 mg/1000 mg: bottles of 30 and 260.

Contraindications

Type 1 diabetes; metabolic acidosis; history of lactic acidosis; severe renal impairment (eGFR < 30 mL/min/1.73 m2); excessive alcohol intake; severe hepatic dysfunction; pregnancy/breastfeeding.

Warnings and precautions

Serious Warning: Lactic acidosis (rare but fatal complication). Risk of pancreatitis. Avoid excessive alcohol. Monitor renal function regularly. Risk of hypoglycemia with insulin secretagogues.

What can be used instead?

Other Canadian products sharing ATC code A10BD07 METFORMIN AND SITAGLIPTIN. 46 of 63 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

ProductStrengthFormManufacturerHealth Canada statusDIN
AG-SITAGLIPTIN HYDROCHLORIDE / METFORMIN1000 MGTABLETANGITA PHARMA INC.MARKETEDDIN 02557746
AG-SITAGLIPTIN HYDROCHLORIDE / METFORMIN500 MGTABLETANGITA PHARMA INC.MARKETEDDIN 02557711
AG-SITAGLIPTIN HYDROCHLORIDE / METFORMIN850 MGTABLETANGITA PHARMA INC.MARKETEDDIN 02557738
APO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE1000 MGTABLETAPOTEX INCMARKETEDDIN 02509431
APO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE50 MGTABLETAPOTEX INCMARKETEDDIN 02509415
APO-SITAGLIPTIN MALATE / METFORMIN HYDROCHLORIDE850 MGTABLETAPOTEX INCMARKETEDDIN 02509423
APO-SITAGLIPTIN-METFORMIN50 MGTABLETAPOTEX INCMARKETEDDIN 02435799
APO-SITAGLIPTIN-METFORMIN500 MGTABLETAPOTEX INCMARKETEDDIN 02435772
APO-SITAGLIPTIN-METFORMIN850 MGTABLETAPOTEX INCMARKETEDDIN 02435780
APO-SITAGLIPTIN/METFORMIN XR1000 MGTABLET (EXTENDED-RELEASE)APOTEX INCMARKETEDDIN 02506297

Who else supplies METFORMIN AND SITAGLIPTIN worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. METFORMIN AND SITAGLIPTIN appears in 1377 registered pack listings across 12 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.

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 SANDOZ SITAGLIPTIN-METFORMIN XR

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.

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.

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.

Related pages

Sourcing this product