aminocaproic acid

Generic: aminocaproic acid

Labeler: apozeal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aminocaproic acid
Generic Name aminocaproic acid
Labeler apozeal pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

aminocaproic acid .25 g/mL

Manufacturer
Apozeal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 83745-294
Product ID 83745-294_98a1b6f4-8251-489a-94da-f98fc1d57d7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213216
Listing Expiration 2026-12-31
Marketing Start 2025-11-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83745294
Hyphenated Format 83745-294

Supplemental Identifiers

RxCUI
582299
UPC
0383745294089
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 ANDA213216 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 g/mL
source: ndc
Packaging
  • 236.5 mL in 1 BOTTLE (83745-294-08)
source: ndc

Packages (1)

83745-294-08 236.5 mL in 1 BOTTLE (83745-294-08)

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": "98a1b6f4-8251-489a-94da-f98fc1d57d7e", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0383745294089"], "unii": ["U6F3787206"], "rxcui": ["582299"], "spl_set_id": ["15aa2f36-ccc6-431a-99a2-45d812ef4bbf"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Apozeal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236.5 mL in 1 BOTTLE (83745-294-08)", "package_ndc": "83745-294-08", "marketing_start_date": "20251110"}], "brand_name": "Aminocaproic Acid", "product_id": "83745-294_98a1b6f4-8251-489a-94da-f98fc1d57d7e", "dosage_form": "SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "83745-294", "generic_name": "Aminocaproic Acid", "labeler_name": "Apozeal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminocaproic Acid", "active_ingredients": [{"name": "AMINOCAPROIC ACID", "strength": ".25 g/mL"}], "application_number": "ANDA213216", "marketing_category": "ANDA", "marketing_start_date": "20251110", "listing_expiration_date": "20261231"}