Aminocaproic Acid
Aminocaproic Acid Tablets USP 500 mg, 1000 mg and Oral Solution 0.25 g/mL
Approved
Approval ID
f90e9443-78d3-4709-b6be-ee9aacef2afb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2022
Manufacturers
FDA
Akorn Operating Company LLC
DUNS: 117693100
Products 3
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 Code17478-769
Application NumberNDA015197
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateJuly 6, 2022
Generic NameAminocaproic Acid
INGREDIENTS (5)
AMINOCAPROIC ACIDActive
Quantity: 1000 mg in 1 1
Code: U6F3787206
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Aminocaproic Acid
PRODUCT DETAILS
NDC Product Code17478-768
Application NumberNDA015197
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateJuly 6, 2022
Generic NameAminocaproic Acid
INGREDIENTS (5)
AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Aminocaproic Acid
PRODUCT DETAILS
NDC Product Code17478-447
Application NumberNDA015230
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateJuly 6, 2022
Generic NameAminocaproic Acid
INGREDIENTS (10)
AMINOCAPROIC ACIDActive
Quantity: 0.25 g in 1 mL
Code: U6F3787206
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUM ANHYDROUSInactive
Code: I4807BK602
Classification: IACT
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT