NDC 13913-002

Glumetza

Metformin Hydrochloride

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

Product ID13913-002_121fc3e0-33fe-41af-a7ef-e6b54ee60ef6
NDC13913-002
Product TypeHuman Prescription Drug
Proprietary NameGlumetza
Generic NameMetformin Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-08-01
Marketing CategoryNDA / NDA
Application NumberNDA021748
Labeler NameDepomed, Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 13913-002-13

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13913-002-13)
Marketing Start Date2006-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13913-002-13 [13913000213]

Glumetza TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-08-01
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:4383c6ec-53ad-4c79-b0af-316b3284b2fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861018
  • 1807915
  • 1807888
  • 861015
  • UPC Code
  • 0313913003168
  • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]

    Medicade Reported Pricing

    13913000213 GLUMETZA ER 500 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    68012-002GlumetzaGlumetza
    68012-003GlumetzaGlumetza
    68012-004GlumetzaGlumetza
    13913-002GlumetzaGlumetza
    13913-003GlumetzaGlumetza
    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 [Glumetza]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLUMETZA
    GLUMETZA
    78340355 3366577 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2003-12-12

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