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 | 7251600180672516001806 | 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.NDC labeler code 72516
- 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.
About NDC 72516-018
- What is NDC 72516-018?
- 72516-018 is the product NDC for Ticagrelor, Ticagrelor 90 mg/1 tablet, listed with the FDA by Oryza Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ticagrelor.
- What is the active ingredient?
- Ticagrelor.
- Who is the labeler?
- Oryza Pharmaceuticals, Inc., NDC labeler code 72516. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ticagrelor?
- 51 other product NDCs are listed under this name. See all Ticagrelor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ticagrelor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ticagrelor | Ticagrelor 60 mg/1 | TabletOral | Laurus Labs Limited | 42385-993 | 42385-0993-0142385-0993-0542385-0993-11+4 more |
| Ticagrelor | Ticagrelor 90 mg/1 | TabletOral | Laurus Labs Limited | 42385-994 | 42385-0994-0142385-0994-0542385-0994-11+4 more |
| Ticagrelor | Ticagrelor 60 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-940 | 72603-0940-01 |
| Ticagrelor | Ticagrelor 90 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-941 | 72603-0941-0172603-0941-02 |
| Ticagrelor | Ticagrelor 60 mg/1 | TabletOral | AiPing Pharmaceutical, Inc | 11788-157 | 11788-0157-60 |
| Ticagrelor | Ticagrelor 90 mg/1 | TabletOral | AiPing Pharmaceutical, Inc | 11788-158 | 11788-0158-0111788-0158-60 |
| Ticagrelor | Ticagrelor 60 mg/1 | TabletOral | American Health Packaging | 60687-935 | 60687-0935-21 |
| Ticagrelor | Ticagrelor 60 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-047 | 70756-0047-60 |
| Ticagrelor | Ticagrelor 90 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-048 | 70756-0048-6070756-0048-99 |
| Ticagrelor | Ticagrelor 90 mg/1 | TabletOral | American Health Packaging | 60687-928 | 60687-0928-57 |
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 |