NDC 68012-003

Glumetza

Metformin Hydrochloride

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

Product ID68012-003_039bd4a8-cf35-4946-8079-ca0aef70b829
NDC68012-003
Product TypeHuman Prescription Drug
Proprietary NameGlumetza
Generic NameMetformin Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-06-17
Marketing CategoryNDA / NDA
Application NumberNDA021748
Labeler NameSantarus, Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength1000 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68012-003-16

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-003-16)
Marketing Start Date2008-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68012-003-16 [68012000316]

Glumetza TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021748
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-06-17

NDC 68012-003-97 [68012000397]

Glumetza TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-17
Marketing End Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

OpenFDA Data

SPL SET ID:fb832474-88d9-4e29-95cd-fbc446944cc4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861018
  • 1807915
  • 1807888
  • 861015
  • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]

    Medicade Reported Pricing

    68012000316 GLUMETZA ER 1,000 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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