FDA Product

Midodrine Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Midodrine Hydrochloride

FDA Product Code

55154-5696

Regulatory Information

NDC Product Code

55154-5696

Application Number

ANDA076577

Marketing Category

C73584

Effective Date

January 25, 2024

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

12

Company Information

ManufacturerCardinal Health 107, LLC

DUNS Number

118546603

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 200

Code: 5XDI2TS1EZ

Class Code: IACT

MIDODRINE HYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: 59JV96YTXV

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

MIDODRINE

Code: 6YE7PBM15H

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