Midodrine hydrochloride

Basic Information

Product Name

FDA Product Code

68382-738

Regulatory Information

NDC Product Code

68382-738

Application Number

ANDA213055

Marketing Category

C73584

Effective Date

March 26, 2024

Territorial Authority

USA

FDA Title

Midodrine Hydrochloride Tablets, USP Rx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MIDODRINE HYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: 59JV96YTXV

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

Active Moieties

MIDODRINE

Code: 6YE7PBM15H

Basic Information

Regulatory Information

Company Information

Active Ingredients

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

SILICON DIOXIDE

STARCH, CORN

CROSCARMELLOSE SODIUM

Active Moieties

MIDODRINE