AMINOCAPROIC ACID
Aminocaproic Acid Tablets, USPRx only
Approved
Approval ID
7d08ad63-71f5-4286-9622-84295668a293
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
DUNS: 080210964
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 Code24658-799
Application NumberANDA213928
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMINOCAPROIC ACID
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification
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
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
AMINOCAPROIC ACID
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24658-798
Application NumberANDA213928
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMINOCAPROIC ACID
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (5)
AMINOCAPROIC ACIDActive
Quantity: 500 mg in 1 1
Code: U6F3787206
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/15/2023
Container Label of 1000 mg 30ct
