aminocaproic acid

Generic: aminocaproic acid

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name aminocaproic acid
Generic Name aminocaproic acid
Labeler bpi labs llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

aminocaproic acid .25 g/mL

Manufacturer
BPI LABS LLC

Identifiers & Regulatory

Product NDC 54288-151
Product ID 54288-151_f8d071d1-03b0-4b2b-b766-9304fd9834fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213825
Listing Expiration 2027-12-31
Marketing Start 2022-05-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288151
Hyphenated Format 54288-151

Supplemental Identifiers

RxCUI
582299
UPC
0354288151016
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 ANDA213825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 g/mL
source: ndc
Packaging
  • 236.5 mL in 1 BOTTLE, PLASTIC (54288-151-01)
source: ndc

Packages (1)

54288-151-01 236.5 mL in 1 BOTTLE, PLASTIC (54288-151-01)

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": "f8d071d1-03b0-4b2b-b766-9304fd9834fb", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0354288151016"], "unii": ["U6F3787206"], "rxcui": ["582299"], "spl_set_id": ["cfa601c4-b649-417e-a301-b246f080f1eb"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["BPI LABS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236.5 mL in 1 BOTTLE, PLASTIC (54288-151-01)", "package_ndc": "54288-151-01", "marketing_start_date": "20220516"}], "brand_name": "Aminocaproic acid", "product_id": "54288-151_f8d071d1-03b0-4b2b-b766-9304fd9834fb", "dosage_form": "SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "54288-151", "generic_name": "Aminocaproic acid", "labeler_name": "BPI LABS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminocaproic acid", "active_ingredients": [{"name": "AMINOCAPROIC ACID", "strength": ".25 g/mL"}], "application_number": "ANDA213825", "marketing_category": "ANDA", "marketing_start_date": "20220516", "listing_expiration_date": "20271231"}