Aminocaproic Acid NDC 69680-116

NDC codes

FDA NDC Directory

Product NDC (as listed)69680-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69680-0116Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
69680-116-00	69680011600	100 TABLET in 1 BOTTLE (69680-116-00)Marketed from Dec 3, 2018
69680-116-30	69680011630	30 TABLET in 1 BOTTLE (69680-116-30)Marketed from Dec 3, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Aminocaproic Acid
Generic name (nonproprietary): aminocaproic acid
Active ingredients: Aminocaproic acid — 1000 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Vitruvias Therapeutics
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209060
Marketing start: Dec 3, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Fibrinolysis (Physiologic effect)
Identifiers: Product ID 69680-116_236ce9f5-3f2f-438f-a82d-04fc57314bf7SPL ID 236ce9f5-3f2f-438f-a82d-04fc57314bf7SPL set ID 555a0910-dbeb-4643-8b3a-c9fe9b803b3cRxCUI 197351, 476271UNII U6F3787206UPC 0369680116303, 0369680115306
Pharmacologic class: Antifibrinolytic Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469680011600 followed by a unit qualifier and the quantity

Package 69680-0116-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 15, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Aminocaproic Acid Tablets is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209060

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209060
Product	Strength	Form · route	Labeler	Product NDC
Aminocaproic Acid	Aminocaproic acid 500 mg/1	TabletOral	Vitruvias Therapeutics	69680-115
Aminocaproic Acid	Aminocaproic acid 500 mg/1	TabletOral	American Health Packaging	60687-739