Midodrine Hydrochloride

Basic Information

Product Name

FDA Product Code

82293-005

Regulatory Information

NDC Product Code

82293-005

Application Number

ANDA211973

Marketing Category

C73584

Effective Date

October 20, 2023

Territorial Authority

USA

FDA Title

Midodrine Hydrochloride Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

MIDODRINE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: 59JV96YTXV

Class Code: ACTIB

Active Moieties

MIDODRINE

Code: 6YE7PBM15H

Basic Information

Regulatory Information

Company Information

Active Ingredients

SILICON DIOXIDE

CROSCARMELLOSE SODIUM

CELLULOSE, MICROCRYSTALLINE

STARCH, CORN

MAGNESIUM STEARATE

SODIUM LAURYL SULFATE

Active Moieties

MIDODRINE