NDC 10631-019

RIOMET ER

Metformin Hydrochloride

RIOMET ER is a Oral For Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries Inc.. The primary component is Metformin Hydrochloride.

Product ID10631-019_c3d89722-7830-4713-b906-bdb86fae98ca
NDC10631-019
Product TypeHuman Prescription Drug
Proprietary NameRIOMET ER
Generic NameMetformin Hydrochloride
Dosage FormFor Suspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-09-10
Marketing CategoryNDA / NDA
Application NumberNDA212595
Labeler NameSun Pharmaceutical Industries Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength500 mg/5mL
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10631-019-17

473 mL in 1 BOTTLE (10631-019-17)
Marketing Start Date2019-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10631-019-17 [10631001917]

RIOMET ER FOR SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA212595
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-10

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/5mL

OpenFDA Data

SPL SET ID:5ed47329-b89e-4aa2-89b6-157c85d4eb56
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2200518
  • 2200520
    • UPC Code
  • 0310631019174

    • NDC Crossover Matching brand name "RIOMET ER" or generic name "Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    10631-019RIOMET ERRIOMET ER
    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

    Trademark Results [RIOMET ER]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RIOMET ER
    RIOMET ER
    98046568 not registered Live/Pending
    Sun Pharmaceutical Industries Limited
    2023-06-16
    RIOMET ER
    RIOMET ER
    88731302 not registered Live/Pending
    Sun Pharmaceutical Industries Limited
    2019-12-18
    RIOMET ER
    RIOMET ER
    88228966 not registered Live/Pending
    Sun Pharmaceutical Industries Limited
    2018-12-13
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