Midodrine Hydrochloride

Basic Information

Product Name

FDA Product Code

70985-006

Regulatory Information

NDC Product Code

70985-006

Application Number

ANDA207613

Marketing Category

C73584

Effective Date

December 23, 2023

Territorial Authority

USA

FDA Title

MIDODRINE HYDROCHLORIDE TABLETS, USP 2.5 mg, 5 mg and 10 mg

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MIDODRINE HYDROCHLORIDE

Quantity: 2.5 mg in 1 1

Code: 59JV96YTXV

Class Code: ACTIB

Active Moieties

MIDODRINE

Code: 6YE7PBM15H

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSCARMELLOSE SODIUM

MAGNESIUM STEARATE

CELLULOSE, MICROCRYSTALLINE

STARCH, CORN

SODIUM LAURYL SULFATE

SILICON DIOXIDE

Active Moieties

MIDODRINE