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DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Active substance: DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE · DAPAGLIFLOZIN 5 mg/1, METFORMIN HYDROCHLORIDE 1000 mg/1

United StatesActive

Marketing holder: Lupin Pharmaceuticals, Inc.

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Products containing dapagliflozin in other countries

Showing products with this active substance, combinations included; the full composition is shown for each product.

CountryProducts
EU 2
  • Dapagliflozin Viatris
    dapagliflozin
    EMEA/H/C/006006
    Viatris Limited
  • Qtrilmet
    metformin hydrochloride, saxagliptin, dapagliflozin
    EMEA/H/C/004910
    AstraZeneca AB
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-278d-7918-a60e-ce38f5d3cb2f,01a1208d-1711-7bd1-a763-4fbee36f6760,01a1208d-2eb2-7706-84c6-467b0cec14aa,01a1208d-2eb5-78f7-861a-881d74b321ec,01a1208d-83c7-7983-ba67-9e7cbb55b234;count=38 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
70748-102
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 70748-102 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 70748-102 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 70748-102 · Verified 2026-10-09 · open in source
  • ingredients.1 · openFDA NDC · 70748-102 · Verified 2026-10-09 · open in source