NDC 0087-6063

GLUCOPHAGE XR

Metformin Hydrochloride

GLUCOPHAGE XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bristol-myers Squibb Company. The primary component is Metformin Hydrochloride.

Product ID0087-6063_016f4c35-8adc-4729-a2b6-d76ea7f14eb8
NDC0087-6063
Product TypeHuman Prescription Drug
Proprietary NameGLUCOPHAGE XR
Generic NameMetformin Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryNDA / NDA
Application NumberNDA021202
Labeler NameBristol-Myers Squibb Company
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0087-6063-13

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0087-6063-13)
Marketing Start Date2009-06-01
Marketing End Date2021-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0087-6063-13 [00087606313]

GLUCOPHAGE XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021202
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01
Marketing End Date2021-09-30

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:4a0166c7-7097-4e4a-9036-6c9a60d08fc6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861010
  • 861008
  • 861012
  • 860981
  • 860983
  • 860975
  • 860977
  • 861007
  • 861006
  • 861004
  • UPC Code
  • 0300876063131
  • 0300876060055
  • 0300876070054
  • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]

    NDC Crossover Matching brand name "GLUCOPHAGE XR" or generic name "Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    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 [GLUCOPHAGE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLUCOPHAGE
    GLUCOPHAGE
    97231961 not registered Live/Pending
    Merck Santé S.A.S.
    2022-01-21
    GLUCOPHAGE
    GLUCOPHAGE
    73808940 1652866 Live/Registered
    LIPHA, LYONNAISE INDUSTRIELLE PHARMACEUTIQUE
    1989-06-26
    GLUCOPHAGE
    GLUCOPHAGE
    73549777 not registered Dead/Abandoned
    SOCIETE NOUVELLE D'EXPLOITATION DES LABORATOIRES ARON (S.A.R.L.)
    1985-07-24
    GLUCOPHAGE
    GLUCOPHAGE
    73302961 1232465 Dead/Cancelled
    Aron-Samuel; Jan Marcel Didier
    1981-03-26

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.