MedPath

Acarbose

Acarbose Tablets

Approved
Approval ID

a474a365-d93a-4c6e-a479-0004b7ac4d2c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 6, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-4952
Application NumberANDA090912
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2022
FDA Product Classification

INGREDIENTS (5)

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

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Acarbose - FDA Drug Approval Details