Prescription drug · ANDA
Ticagrelor NDC 71610-914
Ticagrelor 90 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-914-41 | 71610091441 | 5400 TABLET, FILM COATED in 1 BOTTLE (71610-914-41)Marketed from Jun 13, 2025 | |
| 71610-914-42 | 71610091442 | 1800 TABLET, FILM COATED in 1 BOTTLE (71610-914-42)Marketed from Jan 16, 2026 |
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)
- Ticagrelor
- Generic name (nonproprietary)
- ticagrelor
- Active ingredients
- Ticagrelor — 90 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208537
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P-Glycoprotein Inhibitors (Mechanism)P2Y12 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71610-914_4887c1b7-be57-6eb9-e063-6294a90ab88dSPL ID 4887c1b7-be57-6eb9-e063-6294a90ab88dSPL set ID 37b2d081-c17a-c126-e063-6394a90a5729RxCUI 1116635UNII GLH0314RVC
- Pharmacologic class
- P2Y12 Platelet 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
N471610091441followed by a unit qualifier and the quantityPackage 71610-0914-41. 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)
Ticagrelor tablets are a P2Y12 platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. ( 1.1 ) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets were established in a population with type 2 diabetes mellitus (T2DM). ( 1.2 ) to re…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208537
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 |
|---|---|---|---|---|
| Ticagrelor | Ticagrelor 60 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-989 |
| Ticagrelor | Ticagrelor 90 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-991 |
| Ticagrelor | Ticagrelor 90 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-550 |
| Ticagrelor | Ticagrelor 60 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc | 76282-584 |