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Glipita-M 50/1000 Tablets

NAFDAC Reg. No. B4-7628 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Glipita-M 50/1000 Tablets
NAFDAC number
B4-7628
Active ingredient
Sitagliptin (Sitagliptin Phosphate Monohydrate)
Strength
50 mg
Form
Tablet
Pack size
3 x 10's (in PVC-Alu blisters)
Manufacturer
Not listed
Applicant (holder)
Standard Generics Limited
Approved
27 Jul 2023
Status
Active View on NAFDAC ↗
Registration valid to
26 Jul 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Glipita-M 50/1000 Tablets is on the NAFDAC register with an active registration (B4-7628). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Glipita-M 50/1000 Tablets is used for

From the official U.S. FDA label for sitagliptin (sitagliptin phosphate monohydrate), the active ingredient registered with NAFDAC.

What it is used for

JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes ( 1 ) JANUVIA has not been studied in patients with a history of pancreatitis. ( 1 , 5.1 ) Limitations of Use JANUVIA should not be used in patients with type 1 diabetes. JANUVIA has not been studied in patients with a history of pancreatitis. …

Possible side effects

The following adverse reactions are also discussed elsewhere in the labeling: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Acute Renal Failure [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] Bullous Pemphigoid [see Warnings and Precautions (5.7) ] Adverse reactions reported in ≥5% of patients treated with JANUVIA and more commonly than in patients treated with placebo are: upper respiratory tract infecti …

Do not use if

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions (5.5) ; Adverse Reactions (6.2) .] History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema ( 5.5 , 6.2 )

Warnings

Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA. ( 5.1 ) Heart failure : Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of JANUVIA in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.2 ) Acute Renal Failure: Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary The limited available data with JANUVIA in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ]. …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Glipita-M 50/1000 Tablets

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Glipita-M 50/1000 Tablets

What is in Glipita-M 50/1000 Tablets?

Glipita-M 50/1000 Tablets contains Sitagliptin (Sitagliptin Phosphate Monohydrate) (50 mg), as tablet, according to its NAFDAC registration record.

Is Glipita-M 50/1000 Tablets registered with NAFDAC?

Yes. Glipita-M 50/1000 Tablets is listed on the NAFDAC register under registration number B4-7628, and its registration is active as of 5 November 2026.

Has Glipita-M 50/1000 Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Glipita-M 50/1000 Tablets in our automatically synced alert list.

How can I check that my pack of Glipita-M 50/1000 Tablets is genuine?

Run a free authenticity scan with the NAFDAC number B4-7628, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Glipita-M 50/1000 Tablets used for?

JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes ( 1 ) JANUVIA has n (Summarised from the official U.S. FDA label for sitagliptin (sitagliptin phosphate monohydrate). Always follow your doctor or pharmacist.)

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