NDC 61919-769

METFORMIN HYDROCHLORIDE E/R

Metformin Hydrochloride

METFORMIN HYDROCHLORIDE E/R is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Metformin Hydrochloride.

Product ID61919-769_5d521bf8-32c4-25dc-e053-2991aa0ad3cc
NDC61919-769
Product TypeHuman Prescription Drug
Proprietary NameMETFORMIN HYDROCHLORIDE E/R
Generic NameMetformin Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-11-06
Marketing CategoryANDA / ANDA
Application NumberANDA201991
Labeler NameDirectRX
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-769-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-769-60)
Marketing Start Date2017-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-769-60 [61919076960]

METFORMIN HYDROCHLORIDE E/R TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201991
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-06

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:cc4f5988-cf23-4d6f-8108-5eb6ef8633a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860975
  • Pharmacological Class

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

    NDC Crossover Matching brand name "METFORMIN HYDROCHLORIDE E/R" or generic name "Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    61919-769METFORMIN HYDROCHLORIDE E/RMETFORMIN HYDROCHLORIDE E/R
    0087-6060GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0087-6063GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0087-6064GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0087-6070GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    0087-6071GLUCOPHAGEMETFORMIN HYDROCHLORIDE
    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
    0378-7185Metformin 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

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