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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-049
Application NumberANDA212938
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic acid
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-286
Application NumberANDA212938
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aminocaproic acid
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2023
FDA Product Classification
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