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 ID: 0009-5013_7089ba7f-1262-4c79-9097-02c2086774b0
• NDC: 0009-5013
• Product Type: Human Prescription Drug
• Proprietary Name: Glyset
• Generic Name: Miglitol
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1996-12-18
• Marketing Category: NDA / NDA
• Application Number: NDA020682
• Labeler Name: Pharmacia and Upjohn Company LLC
• Substance Name: MIGLITOL
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0009-5013-01

100 TABLET, FILM COATED in 1 BOTTLE (0009-5013-01)

• Marketing Start Date: 1996-12-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0009-5013-01 [00009501301]

Glyset TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020682
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-12-18

Drug Details

Active Ingredients

Ingredient	Strength
MIGLITOL	50 mg/1

OpenFDA Data

• SPL SET ID: 75711d16-2d27-476e-a312-d5af448a0e25
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 0V5436JAQW
• 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"

NDC	Brand Name	Generic Name
0009-5012	Glyset	miglitol
0009-5013	Glyset	miglitol
0009-5014	Glyset	miglitol
57664-684	Miglitol	Miglitol
57664-685	Miglitol	Miglitol
57664-686	Miglitol	Miglitol
69367-303	Miglitol	Miglitol
69367-304	Miglitol	Miglitol
69367-305	Miglitol	Miglitol
71205-935	Miglitol	Miglitol
71205-936	Miglitol	Miglitol
71205-937	Miglitol	Miglitol
76333-125	Miglitol	Miglitol
76333-126	Miglitol	Miglitol
76333-127	Miglitol	Miglitol