NDC 59630-575

FORTAMET

Metformin Hydrochloride

FORTAMET is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Shionogi Inc.. The primary component is Metformin Hydrochloride.

Product ID59630-575_2f478417-f529-4b9d-9489-3945f272a283
NDC59630-575
Product TypeHuman Prescription Drug
Proprietary NameFORTAMET
Generic NameMetformin Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2004-04-27
Marketing CategoryNDA / NDA
Application NumberNDA021574
Labeler NameShionogi Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength1000 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 59630-575-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59630-575-60)
Marketing Start Date2004-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59630-575-99 [59630057599]

FORTAMET TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021574
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-04-27
Marketing End Date2019-01-16

NDC 59630-575-60 [59630057560]

FORTAMET TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021574
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-04-27

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

OpenFDA Data

SPL SET ID:ed71d7ea-f5af-4406-8b0d-68e17cb1e61e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1807917
  • 860998
  • 1807894
  • 861002

    • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]
    • Biguanide [EPC]
    • Biguanides [CS]

    Medicade Reported Pricing

    59630057560 FORTAMET ER 1,000 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "FORTAMET" or generic name "Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    59630-574FORTAMETFORTAMET
    59630-575FORTAMETFORTAMET
    0087-6060GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0087-6063GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0087-6064GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0087-6070GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0087-6071GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0093-1048Metformin HydrochlorideMetformin Hydrochloride
    0093-1049Metformin HydrochlorideMetformin Hydrochloride
    0093-7212Metformin HydrochlorideMetformin Hydrochloride
    0093-7214Metformin HydrochlorideMetformin Hydrochloride
    0093-7267Metformin HydrochlorideMetformin Hydrochloride
    0179-1979Metformin HydrochlorideMetformin Hydrochloride
    0185-4416metformin hydrochloridemetformin hydrochloride
    0378-7185Metformin Hydrochloridemetformin hydrochloride
    0378-7186Metformin Hydrochloridemetformin hydrochloride
    0378-7187Metformin Hydrochloridemetformin hydrochloride
    0440-5739Metformin HydrochlorideMetformin Hydrochloride
    0440-5745Metformin HydrochlorideMetformin Hydrochloride
    0440-5746Metformin HydrochlorideMetformin Hydrochloride
    0591-2411Metformin HydrochlorideMetformin Hydrochloride
    0591-2412Metformin HydrochlorideMetformin Hydrochloride
    0591-2719Metformin HydrochlorideMetformin Hydrochloride
    0591-2720Metformin HydrochlorideMetformin Hydrochloride
    0615-5583Metformin HydrochlorideMetformin Hydrochloride
    0615-7626Metformin HydrochlorideMetformin Hydrochloride
    0615-7627Metformin HydrochlorideMetformin Hydrochloride
    0615-7628Metformin HydrochlorideMetformin Hydrochloride
    0615-7661Metformin HydrochlorideMetformin Hydrochloride
    0615-7662Metformin HydrochlorideMetformin Hydrochloride
    0615-7663Metformin HydrochlorideMetformin Hydrochloride
    0615-7847METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
    0615-7982Metformin HydrochlorideMetformin Hydrochloride
    0615-8015Metformin HydrochlorideMetformin Hydrochloride

    Trademark Results [FORTAMET]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FORTAMET
    FORTAMET
    78115656 2929566 Live/Registered
    SHIONOGI INC.
    2002-03-18
    FORTAMET
    FORTAMET
    73761033 1584321 Dead/Cancelled
    ENKA B.V.
    1988-10-31
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.