AMICAR
AMICAR (aminocaproic acid) Oral Solution and Tablets
Approved
Approval ID
2238c70f-b0b5-4755-896b-45b28777b217
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49411-052
Application NumberNDA015230
Product Classification
M
Marketing Category
C73594
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2022
FDA Product Classification
INGREDIENTS (8)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 0.25 g in 1 mL
Code: U6F3787206
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
Aminocaproic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49411-050
Application NumberNDA015197
Product Classification
M
Marketing Category
C73594
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2022
FDA Product Classification
INGREDIENTS (5)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Aminocaproic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49411-051
Application NumberNDA015197
Product Classification
M
Marketing Category
C73594
G
Generic Name
Aminocaproic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2022
FDA Product Classification
INGREDIENTS (5)
AMINOCAPROIC ACIDActive
Quantity: 1000 mg in 1 1
Code: U6F3787206
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT