NDC 60846-882

Prandin

Repaglinide

Prandin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Gemini Laboratories, Llc. The primary component is Repaglinide.

Product ID60846-882_60cb3375-80f4-7dc7-e053-2a91aa0a6ccd
NDC60846-882
Product TypeHuman Prescription Drug
Proprietary NamePrandin
Generic NameRepaglinide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-02
Marketing CategoryANDA / ANDA
Application NumberANDA077571
Labeler NameGemini Laboratories, LLC
Substance NameREPAGLINIDE
Active Ingredient Strength1 mg/mg
Pharm ClassesGlinide [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 60846-882-01

100 TABLET in 1 BOTTLE (60846-882-01)
Marketing Start Date2017-02-02
Marketing End Date2022-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60846-882-01 [60846088201]

Prandin TABLET
Marketing CategoryANDA
Application NumberANDA077571
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-02
Marketing End Date2022-08-01

Drug Details

Active Ingredients

IngredientStrength
REPAGLINIDE1 mg/mg

OpenFDA Data

SPL SET ID:47910c52-1cbf-70d4-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213220
  • 200256
  • 213219
  • 200258
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0169-0081Prandinrepaglinide
    0169-0082Prandinrepaglinide
    0169-0084Prandinrepaglinide
    68151-3566PrandinPrandin
    68151-3565PrandinPrandin
    60846-882PrandinPrandin
    60846-884PrandinPrandin
    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

    Trademark Results [Prandin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRANDIN
    PRANDIN
    75272035 2330531 Live/Registered
    NOVO NORDISK A/S
    1997-04-09
    PRANDIN
    PRANDIN
    72412854 0954329 Dead/Expired
    UPJOHN COMPANY, THE
    1972-01-17

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