Midodrine Hydrochloride
Approved
Approval ID
0aebf5f9-8cfa-4b77-ba40-821ce0a2b266
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-906
Application NumberANDA207849
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 1, 2022
Generic Namemidodrine hydrochloride
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
midodrine hydrochloride
PRODUCT DETAILS
NDC Product Code71205-904
Application NumberANDA207849
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 1, 2022
Generic Namemidodrine hydrochloride
INGREDIENTS (4)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
midodrine hydrochloride
PRODUCT DETAILS
NDC Product Code71205-905
Application NumberANDA207849
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 1, 2022
Generic Namemidodrine hydrochloride
INGREDIENTS (4)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT