NDC 68788-0397

METFORMIN HYDROCHLORIDE

Metformin Hydrochloride

METFORMIN HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Metformin Hydrochloride.

Product ID68788-0397_c33266cf-2302-47d0-951c-21ea9a6cc7a2
NDC68788-0397
Product TypeHuman Prescription Drug
Proprietary NameMETFORMIN HYDROCHLORIDE
Generic NameMetformin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2002-01-29
Marketing CategoryANDA / ANDA
Application NumberANDA075967
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-0397-9

90 TABLET in 1 BOTTLE (68788-0397-9)
Marketing Start Date2011-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-0397-9 [68788039709]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA075967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-18
Marketing End Date2019-10-28

NDC 68788-0397-3 [68788039703]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA075967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-18
Marketing End Date2019-10-28

NDC 68788-0397-6 [68788039706]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA075967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-18
Marketing End Date2019-10-28

NDC 68788-0397-8 [68788039708]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA075967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-18
Marketing End Date2019-10-28

NDC 68788-0397-1 [68788039701]

METFORMIN HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA075967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-18
Marketing End Date2019-10-28

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:da99b8c4-f85e-409f-93a8-0e4758d74552
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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