NDC 57664-686

Miglitol

Miglitol

Miglitol is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries Ltd.. The primary component is Miglitol.

Product ID57664-686_17a6135f-ebee-4943-a5bf-b35df3d1ca27
NDC57664-686
Product TypeHuman Prescription Drug
Proprietary NameMiglitol
Generic NameMiglitol
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2016-01-04
Marketing CategoryANDA / ANDA
Application NumberANDA203965
Labeler NameSun Pharmaceutical Industries Ltd.
Substance NameMIGLITOL
Active Ingredient Strength100 mg/1
Pharm Classesalpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57664-686-88

100 TABLET, COATED in 1 BOTTLE (57664-686-88)
Marketing Start Date2016-04-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-686-88 [57664068688]

Miglitol TABLET, COATED
Marketing CategoryANDA
Application NumberANDA203965
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-21

Drug Details

Active Ingredients

IngredientStrength
MIGLITOL100 mg/1

OpenFDA Data

SPL SET ID:d6cea949-5b05-4c8e-b37f-40e33659510c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205331
  • 205330
  • 205329
  • UPC Code
  • 0357664686881
  • 0357664685884
  • 0357664684887
  • Pharmacological Class

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

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

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

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