aminocaproic acid

Generic: aminocaproic acid

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aminocaproic acid
Generic Name aminocaproic acid
Labeler amneal pharmaceuticals ny llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

aminocaproic acid .25 g/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1596
Product ID 69238-1596_2b9785d5-ea90-465b-a9f5-2c70e578799a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212780
Listing Expiration 2026-12-31
Marketing Start 2019-08-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381596
Hyphenated Format 69238-1596

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 ANDA212780 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 g/mL
source: ndc
Packaging
  • 10 CUP, UNIT-DOSE in 1 TRAY (69238-1596-4) / 5 mL in 1 CUP, UNIT-DOSE (69238-1596-3)
  • 236.5 mL in 1 BOTTLE, PLASTIC (69238-1596-8)
source: ndc

Packages (2)

69238-1596-4 10 CUP, UNIT-DOSE in 1 TRAY (69238-1596-4) / 5 mL in 1 CUP, UNIT-DOSE (69238-1596-3) 69238-1596-8 236.5 mL in 1 BOTTLE, PLASTIC (69238-1596-8)

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": "2b9785d5-ea90-465b-a9f5-2c70e578799a", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["U6F3787206"], "rxcui": ["582299"], "spl_set_id": ["65efb08a-c1ae-4bb7-a8a2-b7ae26485567"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (69238-1596-4)  / 5 mL in 1 CUP, UNIT-DOSE (69238-1596-3)", "package_ndc": "69238-1596-4", "marketing_start_date": "20190823"}, {"sample": false, "description": "236.5 mL in 1 BOTTLE, PLASTIC (69238-1596-8)", "package_ndc": "69238-1596-8", "marketing_start_date": "20190823"}], "brand_name": "Aminocaproic acid", "product_id": "69238-1596_2b9785d5-ea90-465b-a9f5-2c70e578799a", "dosage_form": "SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "69238-1596", "generic_name": "Aminocaproic acid", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminocaproic acid", "active_ingredients": [{"name": "AMINOCAPROIC ACID", "strength": ".25 g/mL"}], "application_number": "ANDA212780", "marketing_category": "ANDA", "marketing_start_date": "20190823", "listing_expiration_date": "20261231"}