NDC 70518-0355

metformin hydrochloride

Metformin Hydrochloride

metformin hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Metformin Hydrochloride.

Product ID70518-0355_83eb499e-2336-36c5-e053-2991aa0a43b3
NDC70518-0355
Product TypeHuman Prescription Drug
Proprietary Namemetformin hydrochloride
Generic NameMetformin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-03-23
Marketing CategoryANDA / ANDA
Application NumberANDA090564
Labeler NameREMEDYREPACK INC.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0355-0

90 TABLET in 1 BOTTLE, PLASTIC (70518-0355-0)
Marketing Start Date2017-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0355-0 [70518035500]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-23

NDC 70518-0355-6 [70518035506]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-03
Marketing End Date2020-04-27

NDC 70518-0355-4 [70518035504]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-15

NDC 70518-0355-3 [70518035503]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-06
Marketing End Date2020-04-27

NDC 70518-0355-1 [70518035501]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-23

NDC 70518-0355-2 [70518035502]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-27
Marketing End Date2020-04-27

NDC 70518-0355-5 [70518035505]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:38868d4f-5f30-4fa7-8e21-518f1526c4c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861007
  • 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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