Midodrine Hydrochloride
Midodrine Hydrochloride Tablets, USP
Approved
Approval ID
2bf011fe-d114-42a4-93e2-76a993a3ba34
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2023
Manufacturers
FDA
Novugen Pharma (USA) LLC
DUNS: 118312098
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 Code82293-003
Application NumberANDA211973
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
Midodrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82293-004
Application NumberANDA211973
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB
Midodrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82293-005
Application NumberANDA211973
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midodrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MIDODRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 59JV96YTXV
Classification: ACTIB