Aminocaproic acid
Aminocaproic Acid Tablets USP, 500 mg and 1,000 mg Rx only
Approved
Approval ID
c5dc0c33-a0f9-43c4-9f10-3668f4361b87
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2023
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aminocaproic acid
PRODUCT DETAILS
NDC Product Code72205-049
Application NumberANDA212938
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 21, 2023
Generic NameAminocaproic acid
INGREDIENTS (7)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Aminocaproic acid
PRODUCT DETAILS
NDC Product Code72205-286
Application NumberANDA212938
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 21, 2023
Generic NameAminocaproic acid
INGREDIENTS (7)
AMINOCAPROIC ACIDActive
Quantity: 1000 mg in 1 1
Code: U6F3787206
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT