NDC 0904-5794

Metformin Hydrochloride Extended Release

Metformin Hydrochloride

Metformin Hydrochloride Extended Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Metformin Hydrochloride.

Product ID0904-5794_0cfa0079-8df3-432a-a5ae-f0bec7d2aad9
NDC0904-5794
Product TypeHuman Prescription Drug
Proprietary NameMetformin Hydrochloride Extended Release
Generic NameMetformin Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-06-10
Marketing CategoryANDA / ANDA
Application NumberANDA076706
Labeler NameMajor Pharmaceuticals
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0904-5794-61

100 BLISTER PACK in 1 CARTON (0904-5794-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2009-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-5794-61 [00904579461]

Metformin Hydrochloride Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076706
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-10
Marketing End Date2019-01-18

NDC 0904-5794-40 [00904579440]

Metformin Hydrochloride Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-10
Marketing End Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:37a431ab-466c-4f8b-b06d-826d35fd3710
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860975
  • UPC Code
  • 0309045794616
  • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]

    NDC Crossover Matching brand name "Metformin Hydrochloride Extended Release" or generic name "Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    68071-3111METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    68788-6932METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    68788-7337METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    70518-0899METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    71335-0293METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    71335-0889METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    0904-5794Metformin Hydrochloride Extended ReleaseMetformin Hydrochloride Extended Release
    35208-001Metformin Hydrochloride Extended ReleaseMetformin Hydrochloride Extended Release
    35208-002Metformin Hydrochloride Extended ReleaseMetformin Hydrochloride Extended Release
    43063-902METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    49483-624METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    49483-623METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    60760-623METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    61919-450METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    71335-1310METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    72789-009METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    70518-2480METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    70934-334METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    70934-309METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    71610-454METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    72189-064METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
    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

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