Prescription drug · ANDA
Aminocaproic Acid NDC 70377-103
Aminocaproic acid 1000 mg/1 · Tablet · Oral · Biocon Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-103-11 | 70377010311 | 30 TABLET in 1 BOTTLE (70377-103-11)Marketed from Mar 15, 2021 |
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
- Biocon Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213928
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Fibrinolysis (Physiologic effect)
- Identifiers
- Product ID 70377-103_2681dc2f-b544-e29d-90af-ce64675fdd8bSPL ID 2681dc2f-b544-e29d-90af-ce64675fdd8bSPL set ID 9205fb6b-24a0-1138-fd7b-cc33d0df5d6fRxCUI 197351, 476271UNII U6F3787206UPC 0370377103117
- 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
N470377010311followed by a unit qualifier and the quantityPackage 70377-0103-11. 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 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, usualIy a normal physio…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213928
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 | Carnegie Pharmaceuticals, LLC | 80005-128 |
| Aminocaproic Acid | Aminocaproic acid 1000 mg/1 | TabletOral | Carnegie Pharmaceuticals, LLC | 80005-129 |
| Aminocaproic Acid | Aminocaproic acid 500 mg/1 | TabletOral | Biocon Pharma Inc. | 70377-102 |
| Aminocaproic Acid | Aminocaproic acid 500 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-798 |
| Aminocaproic Acid | Aminocaproic acid 1000 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-799 |