Prescription drug · ANDA
apixaban NDC 14445-149
Apixaban 2.5 mg/1 · Tablet, Film coated · Oral · Indoco Remedies Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14445-149-05 | 14445014905 | 500 TABLET, FILM COATED in 1 BOTTLE (14445-149-05)Marketed from Sep 16, 2020 | |
| 14445-149-10 | 14445014910 | 1 TABLET, FILM COATED in 1 CARTON (14445-149-10)Marketed from Sep 16, 2020 | |
| 14445-149-14 | 14445014914 | 1 TABLET, FILM COATED in 1 CARTON (14445-149-14)Marketed from Sep 16, 2020 | |
| 14445-149-18 | 14445014918 | 180 TABLET, FILM COATED in 1 BOTTLE (14445-149-18)Marketed from Sep 16, 2020 | |
| 14445-149-60 | 14445014960 | 60 TABLET, FILM COATED in 1 BOTTLE (14445-149-60)Marketed from Sep 16, 2020 |
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)
- apixaban
- Generic name (nonproprietary)
- apixaban
- Active ingredients
- Apixaban — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Indoco Remedies Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209898
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 14445-149_6a6e421b-6ed3-403c-b07d-09dbbd6a487cSPL ID 6a6e421b-6ed3-403c-b07d-09dbbd6a487cSPL set ID 095a08ac-cf0e-497e-a682-ddef38d6b29cRxCUI 1364435, 1364445UNII 3Z9Y7UWC1J
- 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
N414445014905followed by a unit qualifier and the quantityPackage 14445-0149-05. 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 is 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 De…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209898
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 5 mg/1 | Tablet, Film coatedOral | Indoco Remedies Limited | 14445-150 |