NDC 43353-987

METFORMIN HYDROCHLORIDE

Metformin Hydrochloride

METFORMIN HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Metformin Hydrochloride.

Product ID43353-987_600cc6bc-4c96-40d8-8530-bfaaa5688510
NDC43353-987
Product TypeHuman Prescription Drug
Proprietary NameMETFORMIN HYDROCHLORIDE
Generic NameMetformin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-09-11
Marketing CategoryANDA / ANDA
Application NumberANDA203769
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength1000 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-987-30

30 TABLET in 1 BOTTLE (43353-987-30)
Marketing Start Date2014-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-987-45 [43353098745]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA203769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-05

NDC 43353-987-86 [43353098786]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA203769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-22

NDC 43353-987-73 [43353098773]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA203769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-21

NDC 43353-987-80 [43353098780]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA203769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-02

NDC 43353-987-30 [43353098730]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA203769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-22

NDC 43353-987-53 [43353098753]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA203769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-24

NDC 43353-987-60 [43353098760]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA203769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-02

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

OpenFDA Data

SPL SET ID:273d86b0-9d30-48c9-8918-c5e1ececa951
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861007
  • 861010
  • 861004
  • 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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