Basic Information
Midodrine Hydrochloride
49884-814
Regulatory Information
49884-814
ANDA207169
C73584
October 30, 2018
USA
Midodrine Hydrochloride Tablets, USP Rx only WARNING: Because midodrine hydrochloride can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine hydrochloride in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride, principally improved ability to carry out activities of daily living, have not been verified.
HUMAN PRESCRIPTION DRUG LABEL
10
Company Information
092733690
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
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
Active Moieties
MIDODRINE
Code: 6YE7PBM15H