MIDODRINE HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mg
Approved
Approval ID
9d5c58cc-1713-47ff-acbd-5b1fc79f9944
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-2958
Application NumberANDA076449
Product Classification
M
Marketing Category
C73584
G
Generic Name
MIDODRINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2016
FDA Product Classification
INGREDIENTS (7)
MIDODRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT