OXRA 10 MG TAB

1. All Details: Specifications
Active Pharmaceutical Ingredient: Dapagliflozin Propanediol Monohydrate (equivalent to Dapagliflozin 10 mg)
Dosage Form: Film-coated oral tablet
Coloring Agents: Titanium Dioxide IP & Ferric Oxide (Yellow) USP-NF
Storage Environment: Store below 30°C. Keep out of the reach of children.
Regulatory Classification: Schedule H Prescription Drug Warning – Caution: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Batch Identification: SIF0939A
Date of Manufacture (Mfg. Dt.): 03/2024
Date of Expiration (Exp. Dt.): 11/2026
Maximum Retail Price (M.R.P.): Rs. 217.00 per 14 Tablets (Inclusive of all taxes).
2. General Information
Brand: OXRA 10 mg (stylized as oXRA® 10 mg)
Name: Dapagliflozin Tablets
Quantity: Pack of 14 Tablets (indicated by “14 Tablets” and “per 14 Tablets”).
Type: Prescription Oral Anti-Diabetic Medication (SGLT2 inhibitor).
Factor (Form Factor): Solid oral tablet (Film-coated).
Maximum Shelf Life: 32 months (From March 2024 to November 2026).
Food Preference: Not Applicable. This is a specialized prescription pharmaceutical medication, meaning standard consumer dietary indicators (such as a green vegetarian dot) are not present.
FSSAI: Not Applicable. This therapeutic formula is governed under the Drugs and Cosmetics Act by the CDSCO. It is not a food product or dietary supplement, so it does not fall under the jurisdiction or licensing of the FSSAI (Food Safety and Standards Authority of India).
3. Product Details: Ingredients
Each film-coated tablet contains:
Dapagliflozin Propanediol Monohydrate equivalent to Dapagliflozin: 10 mg
Excipients: q. s. (Quantity Sufficient)
4. Directions: How to Use
Dosage: As directed by the Physician.
Administration Instructions: Tablets should be swallowed whole with water and must not be chewed or crushed. For comprehensive instructions regarding indications, dosage, and side effect precautions, always see the enclosed package insert.
5. Description
Oxra 10 mg is an oral prescription medication used primarily to improve glycemic control in adults with Type 2 Diabetes Mellitus. Its active compound, Dapagliflozin, works as a Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitor, which helps the kidneys remove excess glucose from the bloodstream through the urine. The packaging features a distinct red regulatory strip denoting its status as a prescription-only medicine and includes an integrated QR code on the lower foil segment to check for verification and product authenticity.
6. Manufacturer Information
Manufactured in India by: sun pharma laboratories ltd.
Plant Address: Plot No. 107-108, Namli Block, P.O. Ranipool, East-Sikkim-737135.
Manufacturing License Number (M.L.): M/645/2014
Production Code Reference: 5241193
7. Marketed By
Marketed by: sun pharma laboratories ltd.