Prescription drug · ANDA
Ticagrelor NDC 72516-018
Ticagrelor 90 mg/1 · Tablet · Oral · Oryza Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72516-018-06 | 72516001806 | 60 TABLET in 1 BOTTLE (72516-018-06)Marketed from Apr 15, 2025 · Sample package |
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
- Route
- Oral
- Labeler
- Oryza Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208508
- 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 72516-018_32c950ec-054d-b0f7-e063-6394a90ad41cSPL ID 32c950ec-054d-b0f7-e063-6394a90ad41cSPL set ID 32c950bd-7f5f-a811-e063-6394a90a0080RxCUI 1116635UNII GLH0314RVCUPC 0372516018061
- 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
N472516001806followed by a unit qualifier and the quantityPackage 72516-0018-06. 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 tablet is a P2Y 12 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 reduce 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 was established in a population with type 2 diabetes mellitus (T2DM). (1.2) to reduce th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208508
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 | TabletOral | Oryza Pharmaceuticals, Inc. | 72516-017 |