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Acarbose

Acarbose

Approved
Approval ID

4cbedeb9-d270-4e2f-8cb7-f8a8dfa4a0db

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 30, 2019

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 Code50090-4115
Application NumberNDA020482
Product Classification
M
Marketing Category
C73605
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2019
FDA Product Classification

INGREDIENTS (5)

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

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Acarbose - FDA Drug Approval Details