ISTAMET 50/500 MG TAB

1. All Details: Specifications
Active Formulation Strengths: 50mg Sitagliptin (as Sitagliptin Phosphate Monohydrate IP) and 500mg Metformin Hydrochlo
ride IP per tablet.
Storage Temperature: Store at a temperature not exceeding 25°C.
Storage Protection: Protected from light and moisture.
Regulatory Classifications:
SCHEDULE G PRESCRIPTION DRUG – CAUTION: It is dangerous to take this preparation except under medical supervision.
SCHEDULE H PRESCRIPTION DRUG – CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Batch Number: SIG2203A
Manufacturing Date (Mfg. Dt.): OCT.2025
Expiry Date (Exp. Dt.): SEP.2027
Price: M.R.P. Rs. 176.25 (Incl. of all taxes) per 15 Tablets.
Authentication Feature: Includes a printed QR code with instructions to “Scan QR code and check product authenticity”.
Internal Code: 5243769
2. General
Brand: Istamet 50mg/500mg
Name: Sitagliptin & Metformin Tablets BP
Quantity: Strip of 15 tablets.
Type: Allopathic Prescription Medicine (Antidiabetic formulation).
Factor (Form Factor): Film-coated, solid oral tablets.
Maximum Shelf Life: 23 months (from October 2025 manufacturing to September 2027 expiry).
Food Preference: Not applicable (this is an oral pharmaceutical medication, not a dietary supplement or food product).
FSSAI: Not applicable (regulated under medical manufacturing license number M/645/2014, not FSSAI).
3. Product Details: Ingredients
Each film-coated tablet contains:
Sitagliptin Phosphate Monohydrate IP equivalent to Sitagliptin — 50 mg
Metformin Hydrochloride IP — 500 mg
Excipients — q.s. (quantity sufficient)
Permitted Colors: Titanium Dioxide IP, Ferric Oxide (Red) USP-NF, Ferric Oxide (Yellow) USP-NF, and Lake of Quinoline Yellow.
4. Directions: How to Use
Dosage: As directed by the physician.
Administration: For Oral Use Only.
Safety Precaution: Keep out of the reach and sight of children.
5. Description
The image image_bd48fd.jpg displays the rear foil backing of an Istamet pharmaceutical blister pack containing oral antidiabetic tablets. The packaging features dual red warning labels highlighting its restricted Schedule G and Schedule H statuses. It prominently contains the Sun Pharma corporate logo, distinct batch tracking details stamped at the bottom, and a security QR code for counterfeit prevention.
6. Manufacturer Information
Manufactured by: Sun Pharma Laboratories Ltd.
Manufacturing Facility Address: Plot No. 107-108, Namli Block, P.O. Ranipool, Gangtok, Sikkim-737135.
Manufacturing License Number: M/645/2014
7. Marketed By
Marketed by: Sun Pharma Laboratories Ltd.