MedPath

Acarbose

Acarbose Tablets, USP

Approved
Approval ID

067c0adc-7322-489d-9baa-1d061b37be36

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 30, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acarbose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71335-9725
Application NumberANDA202271
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acarbose
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2022
FDA Product Classification

INGREDIENTS (5)

ACARBOSEActive
Quantity: 50 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Acarbose - FDA Drug Approval Details