aminocaproic acid

Generic: aminocaproic acid

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name aminocaproic acid
Generic Name aminocaproic acid
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

aminocaproic acid 1000 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-1110
Product ID 0054-1110_7b8f0ddb-00fd-4c22-afae-afe636f95f3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA015197
Listing Expiration 2026-12-31
Marketing Start 2019-03-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00541110
Hyphenated Format 0054-1110

Supplemental Identifiers

RxCUI
476271 582299
UPC
0300541110139 0300541100581
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 NDA015197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0054-1110-13)
source: ndc

Packages (1)

0054-1110-13 30 TABLET in 1 BOTTLE (0054-1110-13)

Ingredients (1)

aminocaproic acid (1000 mg/1)

Linked Drug Pages (1)

Aminocaproic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7b8f0ddb-00fd-4c22-afae-afe636f95f3a", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0300541110139", "0300541100581"], "unii": ["U6F3787206"], "rxcui": ["476271", "582299"], "spl_set_id": ["7b8f0ddb-00fd-4c22-afae-afe636f95f3a"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0054-1110-13)", "package_ndc": "0054-1110-13", "marketing_start_date": "20241112"}], "brand_name": "Aminocaproic Acid", "product_id": "0054-1110_7b8f0ddb-00fd-4c22-afae-afe636f95f3a", "dosage_form": "TABLET", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "0054-1110", "generic_name": "Aminocaproic Acid", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminocaproic Acid", "active_ingredients": [{"name": "AMINOCAPROIC ACID", "strength": "1000 mg/1"}], "application_number": "NDA015197", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190312", "listing_expiration_date": "20261231"}