aminocaproic acid

Generic: aminocaproic acid

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aminocaproic acid
Generic Name aminocaproic acid
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

aminocaproic acid .25 g/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-573
Product ID 59651-573_48c6a773-7cde-4271-876a-4570a301f43a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216804
Listing Expiration 2026-12-31
Marketing Start 2022-09-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651573
Hyphenated Format 59651-573

Supplemental Identifiers

RxCUI
582299
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 ANDA216804 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 g/mL
source: ndc
Packaging
  • 236.5 mL in 1 BOTTLE (59651-573-08)
source: ndc

Packages (1)

59651-573-08 236.5 mL in 1 BOTTLE (59651-573-08)

Ingredients (1)

aminocaproic acid (.25 g/mL)

Linked Drug Pages (1)

Aminocaproic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48c6a773-7cde-4271-876a-4570a301f43a", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["U6F3787206"], "rxcui": ["582299"], "spl_set_id": ["48c6a773-7cde-4271-876a-4570a301f43a"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236.5 mL in 1 BOTTLE (59651-573-08)", "package_ndc": "59651-573-08", "marketing_start_date": "20220926"}], "brand_name": "Aminocaproic Acid", "product_id": "59651-573_48c6a773-7cde-4271-876a-4570a301f43a", "dosage_form": "SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "59651-573", "generic_name": "Aminocaproic Acid", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminocaproic Acid", "active_ingredients": [{"name": "AMINOCAPROIC ACID", "strength": ".25 g/mL"}], "application_number": "ANDA216804", "marketing_category": "ANDA", "marketing_start_date": "20220926", "listing_expiration_date": "20261231"}