NDC 0378-7186

Metformin Hydrochloride

Metformin Hydrochloride

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

Product ID0378-7186_591c34f1-d12c-4869-b610-c5ad32db0f95
NDC0378-7186
Product TypeHuman Prescription Drug
Proprietary NameMetformin Hydrochloride
Generic NameMetformin Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-06-03
Marketing CategoryANDA / ANDA
Application NumberANDA075973
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength850 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-7186-05

500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7186-05)
Marketing Start Date2010-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-7186-05 [00378718605]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075973
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-06-03

NDC 0378-7186-91 [00378718691]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075973
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-03
Marketing End Date2016-04-14

NDC 0378-7186-01 [00378718601]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075973
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-03
Marketing End Date2016-04-14

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE850 mg/1

OpenFDA Data

SPL SET ID:4f70f907-08d5-4c2e-a4be-32c6124faa7b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861007
  • 861010
  • 861004
  • UPC Code
  • 0303787187057
  • 0303787185053
  • 0303787186050
  • 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
    0615-8015Metformin HydrochlorideMetformin Hydrochloride
    0615-8289METFORMIN 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

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