NDC 42385-902

Metformin Hydrochloride

Metformin Hydrochloride

Metformin Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Laurus Labs Limited. The primary component is Metformin Hydrochloride.

Product ID42385-902_2c0747fd-dbaa-4e08-bbcf-317f14eda820
NDC42385-902
Product TypeHuman Prescription Drug
Proprietary NameMetformin Hydrochloride
Generic NameMetformin Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA209882
Labeler NameLaurus Labs Limited
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength1000 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42385-902-01

100 TABLET, FILM COATED in 1 BOTTLE (42385-902-01)
Marketing Start Date2019-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42385-902-05 [42385090205]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209882
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

NDC 42385-902-10 [42385090210]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209882
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-15

NDC 42385-902-06 [42385090206]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209882
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

NDC 42385-902-01 [42385090201]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209882
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

OpenFDA Data

SPL SET ID:79e46fdc-6200-4312-a87c-ea9294bf22e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861007
  • 861010
  • 861004
  • UPC Code
  • 0342385904093
  • 0342385903096
  • 0342385902068
  • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]
    • 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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