NDC 76333-127

Miglitol

Miglitol

Miglitol is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Orient Pharma Co., Ltd.. The primary component is Miglitol.

Product ID76333-127_71fe01c0-610b-477e-8709-d194ebde8624
NDC76333-127
Product TypeHuman Prescription Drug
Proprietary NameMiglitol
Generic NameMiglitol
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2015-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA203965
Labeler NameOrient Pharma Co., Ltd.
Substance NameMIGLITOL
Active Ingredient Strength100 mg/1
Pharm Classesalpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 76333-127-11

100 TABLET, COATED in 1 BOTTLE (76333-127-11)
Marketing Start Date2019-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76333-127-12 [76333012712]

Miglitol TABLET, COATED
Marketing CategoryANDA
Application NumberANDA203965
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-23

NDC 76333-127-11 [76333012711]

Miglitol TABLET, COATED
Marketing CategoryANDA
Application NumberANDA203965
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-23

Drug Details

Active Ingredients

IngredientStrength
MIGLITOL100 mg/1

OpenFDA Data

SPL SET ID:192e6ed7-9e8c-4772-9e3b-5912a1c63a31
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205331
  • 205330
  • 205329
  • UPC Code
  • 0376333125124
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.