Midodrine HCl
Midodrine Hydrochloride Tablets 2.5 mg, 5 mg and 10 mg
Approved
Approval ID
4a81751e-1c63-4b0d-8f63-bf7c4d155f22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-181
Application NumberANDA076514
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (5)
MIDODRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT