Prescription drug · ANDA
Aminocaproic Acid NDC 69680-115
Aminocaproic acid 500 mg/1 · Tablet · Oral · Vitruvias Therapeutics
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69680-115-00 | 69680011500 | 100 TABLET in 1 BOTTLE (69680-115-00)Marketed from Dec 3, 2018 | |
| 69680-115-30 | 69680011530 | 30 TABLET in 1 BOTTLE (69680-115-30)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 — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Vitruvias TherapeuticsNDC labeler code 69680
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209060
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 69680-115_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
N469680011500followed by a unit qualifier and the quantityPackage 69680-0115-00. 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 .
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.
About NDC 69680-115
- What is NDC 69680-115?
- 69680-115 is the product NDC for Aminocaproic Acid, Aminocaproic acid 500 mg/1 tablet, listed with the FDA by Vitruvias Therapeutics. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aminocaproic Acid.
- What is the active ingredient?
- Aminocaproic acid.
- Who is the labeler?
- Vitruvias Therapeutics, NDC labeler code 69680. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aminocaproic Acid?
- 33 other product NDCs are listed under this name. See all Aminocaproic Acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aminocaproic Acid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aminocaproic Acid | Aminocaproic acid .25 g/mL | SolutionOral | Florida Pharmaceutical Products, LLC | 71921-175 | 71921-0175-08 |
| Aminocaproic Acid | Aminocaproic acid .25 g/mL | SolutionOral | Apozeal Pharmaceuticals Inc. | 83745-294 | 83745-0294-08 |
| Aminocaproic acid | Aminocaproic acid .25 g/mL | SolutionOral | Novadoz Pharmaceuticals LLC | 72205-032 | 72205-0032-7172205-0032-72 |
| Aminocaproic Acid | Aminocaproic acid .25 g/mL | SolutionOral | Vitruvias Therapeutics | 69680-114 | 69680-0114-08 |
| Aminocaproic acid | Aminocaproic acid 1000 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-286 | 72205-0286-30 |
| Aminocaproic Acid | Aminocaproic acid 500 mg/1 | TabletOral | American Health Packaging | 60687-739 | 60687-0739-25 |
| Aminocaproic Acid | Aminocaproic acid 500 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-798 | 24658-0798-30 |
| Aminocaproic Acid | Aminocaproic acid 1000 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-799 | 24658-0799-30 |
| Aminocaproic Acid | Aminocaproic acid .25 g/mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-035 | 31722-0035-23 |
| Aminocaproic Acid | Aminocaproic acid .25 g/mL | SolutionOral | Aurobindo Pharma Limited | 59651-573 | 59651-0573-08 |
Other NDCs under ANDA 209060
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Aminocaproic Acid | Aminocaproic acid 500 mg/1 | TabletOral | American Health Packaging | 60687-739 |
| Aminocaproic Acid | Aminocaproic acid 1000 mg/1 | TabletOral | Vitruvias Therapeutics | 69680-116 |