aminocaproic acid

Generic: aminocaproic acid

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aminocaproic acid
Generic Name aminocaproic acid
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

aminocaproic acid 250 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-9191
Product ID 0517-9191_eea945f2-15ce-4ac9-b786-90f68f6e634c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071192
Listing Expiration 2026-12-31
Marketing Start 2019-02-01

Pharmacologic Class

Established (EPC)
antifibrinolytic agent [epc]
Physiologic Effect
decreased fibrinolysis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05179191
Hyphenated Format 0517-9191

Supplemental Identifiers

RxCUI
238719
UPC
0305179191253
UNII
U6F3787206
NUI
N0000175634 N0000175632

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name aminocaproic acid (source: ndc)
Generic Name aminocaproic acid (source: ndc)
Application Number ANDA071192 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (0517-9191-25) / 20 mL in 1 VIAL, MULTI-DOSE (0517-9191-01)
source: ndc

Packages (1)

0517-9191-25 25 VIAL, MULTI-DOSE in 1 TRAY (0517-9191-25) / 20 mL in 1 VIAL, MULTI-DOSE (0517-9191-01)

Ingredients (1)

aminocaproic acid (250 mg/mL)

Linked Drug Pages (1)

Aminocaproic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "eea945f2-15ce-4ac9-b786-90f68f6e634c", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0305179191253"], "unii": ["U6F3787206"], "rxcui": ["238719"], "spl_set_id": ["08bfb83e-3ac5-4e66-84a3-fcd4deaf73ae"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (0517-9191-25)  / 20 mL in 1 VIAL, MULTI-DOSE (0517-9191-01)", "package_ndc": "0517-9191-25", "marketing_start_date": "20190201"}], "brand_name": "Aminocaproic Acid", "product_id": "0517-9191_eea945f2-15ce-4ac9-b786-90f68f6e634c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "0517-9191", "generic_name": "Aminocaproic Acid", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminocaproic Acid", "active_ingredients": [{"name": "AMINOCAPROIC ACID", "strength": "250 mg/mL"}], "application_number": "ANDA071192", "marketing_category": "ANDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}