Prescription drug · ANDA
Apixaban NDC 0115-1722
Apixaban 5 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1722-01 | 00115172201 | 10 BLISTER PACK in 1 CARTON (0115-1722-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1722-15)Marketed from Aug 31, 2018 | |
| 0115-1722-03 | 00115172203 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-03)Marketed from Aug 31, 2018 | |
| 0115-1722-13 | 00115172213 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-13)Marketed from Aug 31, 2018 |
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)
- Apixaban
- Generic name (nonproprietary)
- apixaban
- Active ingredients
- Apixaban — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209810
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 0115-1722_ac3db938-22a3-42a0-ac3a-8628d9e0a7cfSPL ID ac3db938-22a3-42a0-ac3a-8628d9e0a7cfSPL set ID 19a60552-374d-4b8b-a8ce-ceae252ea5baRxCUI 1364435, 1364445UNII 3Z9Y7UWC1JUPC 0301151721135, 0301151722132
- Pharmacologic class
- Factor Xa Inhibitor
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
N400115172201followed by a unit qualifier and the quantityPackage 00115-1722-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Apixaban tablets are a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3 , 1.4 , 1.5) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation Apixaban tablets are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 1.2 Prophylaxis of…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209810
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 |
|---|---|---|---|---|
| Apixaban | Apixaban 2.5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 0115-1721 |
- openFDA data updated
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