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
NDC Product Code0115-4233
Application NumberANDA076449
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 27, 2017
Generic NameMIDODRINE HYDROCHLORIDE
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
NDC Product Code0115-4222
Application NumberANDA076449
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 27, 2017
Generic NameMIDODRINE HYDROCHLORIDE
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
NDC Product Code0115-4211
Application NumberANDA076449
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 27, 2017
Generic NameMIDODRINE HYDROCHLORIDE
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