MIDODRINE HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE TABLETS, 2.5 mg, 5 mg and 10 mg
Approved
Approval ID
e2e3db6b-054a-4f63-9936-482663c6395a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 27, 2017
Manufacturers
FDA
Impax Generics
DUNS: 079832487
Products 3
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 Code0115-4233
Application NumberANDA076449
Product Classification
M
Marketing Category
C73584
G
Generic Name
MIDODRINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2017
FDA Product Classification
INGREDIENTS (9)
MIDODRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MIDODRINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-4222
Application NumberANDA076449
Product Classification
M
Marketing Category
C73584
G
Generic Name
MIDODRINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2017
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MIDODRINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-4211
Application NumberANDA076449
Product Classification
M
Marketing Category
C73584
G
Generic Name
MIDODRINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2017
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT