NDC 0378-3123

Repaglinide

Repaglinide

Repaglinide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Repaglinide.

Product ID0378-3123_982ba2c2-0ba7-47f4-ad30-51788f52e634
NDC0378-3123
Product TypeHuman Prescription Drug
Proprietary NameRepaglinide
Generic NameRepaglinide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-22
Marketing End Date2019-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA090252
Labeler NameMylan Pharmaceuticals Inc.
Substance NameREPAGLINIDE
Active Ingredient Strength2 mg/1
Pharm ClassesGlinide [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-3123-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-3123-01)
Marketing Start Date2014-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3123-01 [00378312301]

Repaglinide TABLET
Marketing CategoryANDA
Application NumberANDA090252
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-22
Marketing End Date2019-06-30

NDC 0378-3123-05 [00378312305]

Repaglinide TABLET
Marketing CategoryANDA
Application NumberANDA090252
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-22
Marketing End Date2017-03-29

Drug Details

Active Ingredients

IngredientStrength
REPAGLINIDE2 mg/1

OpenFDA Data

SPL SET ID:45422d96-1673-4419-bdb2-d127bb67fabc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200257
  • 200256
  • 200258
  • Pharmacological Class

    • Glinide [EPC]
    • Potassium Channel Antagonists [MoA]

    NDC Crossover Matching brand name "Repaglinide" or generic name "Repaglinide"

    NDCBrand NameGeneric Name
    0378-3122Repagliniderepaglinide
    0378-3123Repagliniderepaglinide
    0574-0240RepaglinideREPAGLINIDE
    0574-0241RepaglinideREPAGLINIDE
    0574-0242RepaglinideREPAGLINIDE
    51079-539Repagliniderepaglinide
    51991-853REPAGLINIDEREPAGLINIDE
    51991-854REPAGLINIDEREPAGLINIDE
    51991-855REPAGLINIDEREPAGLINIDE
    57237-157RepaglinideRepaglinide
    57237-158RepaglinideRepaglinide
    57237-159RepaglinideRepaglinide
    57664-745RepaglinideRepaglinide
    57664-747RepaglinideRepaglinide
    60429-484REPAGLINIDEREPAGLINIDE
    60429-485REPAGLINIDEREPAGLINIDE
    60429-486REPAGLINIDEREPAGLINIDE
    68084-967RepaglinideRepaglinide
    68084-954RepaglinideRepaglinide
    65862-670RepaglinideRepaglinide
    65862-671RepaglinideRepaglinide
    65862-672RepaglinideRepaglinide
    0169-0081Prandinrepaglinide
    0169-0082Prandinrepaglinide
    0169-0084Prandinrepaglinide

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