Midodrine Hydrochloride
MIDODRINE HYDROCHLORIDE TABLETS, USP 2.5 mg, 5 mg and 10 mg Rx Only
Approved
Approval ID
5e2443c2-f714-4b1d-bf2d-22742f411961
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2023
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 2
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 Code55154-4174
Application NumberANDA077746
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2023
FDA Product Classification
INGREDIENTS (6)
Midodrine HydrochlorideActive
Quantity: 10 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Midodrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-8086
Application NumberANDA077746
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2023
FDA Product Classification
INGREDIENTS (6)
Midodrine HydrochlorideActive
Quantity: 5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT