NDC 0009-5013

Glyset

Miglitol

Glyset is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Miglitol.

Product ID0009-5013_7089ba7f-1262-4c79-9097-02c2086774b0
NDC0009-5013
Product TypeHuman Prescription Drug
Proprietary NameGlyset
Generic NameMiglitol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1996-12-18
Marketing CategoryNDA / NDA
Application NumberNDA020682
Labeler NamePharmacia and Upjohn Company LLC
Substance NameMIGLITOL
Active Ingredient Strength50 mg/1
Pharm Classesalpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0009-5013-01

100 TABLET, FILM COATED in 1 BOTTLE (0009-5013-01)
Marketing Start Date1996-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0009-5013-01 [00009501301]

Glyset TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-12-18

Drug Details

Active Ingredients

IngredientStrength
MIGLITOL50 mg/1

OpenFDA Data

SPL SET ID:75711d16-2d27-476e-a312-d5af448a0e25
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213485
  • 213486
  • 213487
  • 205331
  • 205330
  • 205329
  • UPC Code
  • 0300095014013
  • 0300095012019
  • 0300095013016
  • Pharmacological Class

    • alpha Glucosidase Inhibitors [MoA]
    • alpha-Glucosidase Inhibitor [EPC]

    NDC Crossover Matching brand name "Glyset" or generic name "Miglitol"

    NDCBrand NameGeneric Name
    0009-5012Glysetmiglitol
    0009-5013Glysetmiglitol
    0009-5014Glysetmiglitol
    57664-684MiglitolMiglitol
    57664-685MiglitolMiglitol
    57664-686MiglitolMiglitol
    69367-303MiglitolMiglitol
    69367-304MiglitolMiglitol
    69367-305MiglitolMiglitol
    71205-935MiglitolMiglitol
    71205-936MiglitolMiglitol
    71205-937MiglitolMiglitol
    76333-125MiglitolMiglitol
    76333-126MiglitolMiglitol
    76333-127MiglitolMiglitol

    Trademark Results [Glyset]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLYSET
    GLYSET
    75059230 2249907 Live/Registered
    PFIZER INC.
    1996-02-16
    GLYSET
    GLYSET
    75036167 not registered Dead/Abandoned
    BAYER CORPORATION
    1995-12-22

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