aminocaproic acid

Generic: aminocaproic acid

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aminocaproic acid
Generic Name aminocaproic acid
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

aminocaproic acid 500 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7165
Product ID 0904-7165_78c15c64-2046-4fa2-a82e-a27879403756
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212492
Listing Expiration 2026-12-31
Marketing Start 2019-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047165
Hyphenated Format 0904-7165

Supplemental Identifiers

RxCUI
197351
UNII
U6F3787206
NUI
N0000175634 N0000175632

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 ANDA212492 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7165-07) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7165-07 30 BLISTER PACK in 1 CARTON (0904-7165-07) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

aminocaproic acid (500 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": "78c15c64-2046-4fa2-a82e-a27879403756", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["U6F3787206"], "rxcui": ["197351"], "spl_set_id": ["2612ee97-1723-40f2-99e6-3a736f63200f"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7165-07)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7165-07", "marketing_start_date": "20191130"}], "brand_name": "Aminocaproic acid", "product_id": "0904-7165_78c15c64-2046-4fa2-a82e-a27879403756", "dosage_form": "TABLET", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "0904-7165", "generic_name": "Aminocaproic acid", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminocaproic acid", "active_ingredients": [{"name": "AMINOCAPROIC ACID", "strength": "500 mg/1"}], "application_number": "ANDA212492", "marketing_category": "ANDA", "marketing_start_date": "20191130", "listing_expiration_date": "20261231"}