Prescription drug · ANDA
Aminocaproic Acid NDC 0517-9120
Aminocaproic acid 250 mg/mL · Injection, Solution · Intravenous · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-9120-25 | 00517912025 | 25 VIAL, MULTI-DOSE in 1 TRAY (0517-9120-25) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 30, 1990 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 250 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- American Regent, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071192
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 0517-9120_c62d23ae-6f20-4a53-94e4-4ba5d25b7231SPL ID c62d23ae-6f20-4a53-94e4-4ba5d25b7231SPL set ID f4f65667-c349-420b-b7b7-f20f3a4e4d4eRxCUI 238719UNII U6F3787206UPC 0305179120253
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400517912025followed by a unit qualifier and the quantityPackage 00517-9120-25. 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 Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, 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 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 physiological phenomenon, may fr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071192
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 250 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-9191 |
| Aminocaproic Acid | Aminocaproic acid 250 mg/mL | Injection, SolutionIntravenous | Civica, Inc. | 72572-015 |
| Aminocaproic Acid | Aminocaproic acid 250 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7319 |