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Midodrine Hydrochloride

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.

Approved
Approval ID

5a6705af-bb72-4edb-863a-93a351bd6dba

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 27, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Midodrine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63629-2227
Application NumberANDA207169
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2018
FDA Product Classification

INGREDIENTS (7)

MIDODRINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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Midodrine Hydrochloride - FDA Drug Approval Details