Midodrine hydrochloride
Midodrine Hydrochloride Tablets, USP Rx Only
Approved
Approval ID
b4c4417e-d8fd-46c8-b82f-ffbc8f201752
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1595
Application NumberANDA213055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Midodrine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1596
Application NumberANDA213055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Midodrine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1597
Application NumberANDA213055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (6)
MIDODRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT