Prescription drug · ANDA
Aminocaproic Acid NDC 0409-4346
Aminocaproic acid 250 mg/mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-4346-73 | 00409434673 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4346-73) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-16)Marketed from May 12, 2010 |
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
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070010
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 0409-4346_eddf1507-1869-4ac6-9751-4cb12bdce2c1SPL ID eddf1507-1869-4ac6-9751-4cb12bdce2c1SPL set ID 1c5bc1dd-e9ec-44c1-9281-67ad482315d9RxCUI 1718760UNII U6F3787206
- 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
N400409434673followed by a unit qualifier and the quantityPackage 00409-4346-73. 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 f…
Excerpt only. Read the full label for complete information.
About NDC 0409-4346
- What is NDC 0409-4346?
- 0409-4346 is the product NDC for Aminocaproic Acid, Aminocaproic acid 250 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 1 package NDC, 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?
- Hospira, Inc., NDC labeler code 0409. 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 1000 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-799 | 24658-0799-30 |
| Aminocaproic Acid | Aminocaproic acid 500 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-798 | 24658-0798-30 |
| 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 070010
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 | Henry Schein, Inc. | 0404-9812 |
| Aminocaproic Acid | Aminocaproic acid 250 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7359 |