NDC 42291-611

Metformin Hydrochloride

Metformin Hydrochloride

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

Product ID42291-611_761314b5-7ad0-dc36-e053-2a91aa0add70
NDC42291-611
Product TypeHuman Prescription Drug
Proprietary NameMetformin Hydrochloride
Generic NameMetformin Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-10-04
Marketing CategoryANDA / ANDA
Application NumberANDA078596
Labeler NameAvKARE, Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength750 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-611-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-611-01)
Marketing Start Date2019-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-611-27 [42291061127]

Metformin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-15

NDC 42291-611-50 [42291061150]

Metformin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-15

NDC 42291-611-18 [42291061118]

Metformin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-04

NDC 42291-611-90 [42291061190]

Metformin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-15

NDC 42291-611-01 [42291061101]

Metformin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078596
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-31

NDC 42291-611-10 [42291061110]

Metformin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078596
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-15
Marketing End Date2015-02-24

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE750 mg/1

OpenFDA Data

SPL SET ID:81aab305-7a9f-2123-2221-219afff310f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860981
  • 860975
  • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]

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

    NDCBrand NameGeneric Name
    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
    0378-6001Metformin Hydrochloridemetformin
    0378-6002Metformin Hydrochloridemetformin
    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
    67877-217Metformin HydrochlorideMetformin Hydrochloride
    67877-221Metformin HydrochlorideMetformin Hydrochloride
    67877-218Metformin HydrochlorideMetformin Hydrochloride
    67877-159METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
    67877-414Metformin HydrochlorideMetformin Hydrochloride
    67877-413Metformin HydrochlorideMetformin Hydrochloride
    68071-1781Metformin hydrochlorideMetformin hydrochloride
    68071-1419Metformin hydrochlorideMetformin hydrochloride
    68071-1815Metformin hydrochlorideMetformin hydrochloride
    68071-3117Metformin hydrochlorideMetformin hydrochloride
    68071-3200Metformin hydrochlorideMetformin hydrochloride
    68071-1774Metformin hydrochlorideMetformin hydrochloride
    68071-3226Metformin HydrochlorideMetformin Hydrochloride
    68071-1927METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
    68071-3370METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
    68071-3126Metformin hydrochlorideMetformin hydrochloride
    68071-3212Metformin HydrochlorideMetformin Hydrochloride
    68071-4153Metformin HydrochlorideMetformin Hydrochloride
    68071-4525Metformin hydrochlorideMetformin hydrochloride
    68071-4560Metformin hydrochlorideMetformin hydrochloride
    68071-4605Metformin hydrochlorideMetformin hydrochloride
    68071-4270Metformin HydrochlorideMetformin Hydrochloride

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