NDC 0378-6001

Metformin Hydrochloride

Metformin

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

Product ID0378-6001_b1d71739-26c3-43d3-9088-60bef3689e74
NDC0378-6001
Product TypeHuman Prescription Drug
Proprietary NameMetformin Hydrochloride
Generic NameMetformin
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-08-23
Marketing CategoryANDA / ANDA
Application NumberANDA200690
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength1000 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-6001-91

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91)
Marketing Start Date2016-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6001-91 [00378600191]

Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200690
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-23

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

OpenFDA Data

SPL SET ID:7e41818c-60e9-4bcf-9586-7bb8d33d5e89
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1807917
  • 1807894
  • UPC Code
  • 0303786001910
  • 0303786002917
  • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]
    • Biguanide [EPC]
    • Biguanides [CS]

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

    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
    0615-8015Metformin 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

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