Prescription drug · ANDA
Ticagrelor NDC 60505-4453
Ticagrelor 60 mg/1 · Tablet · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4453-6 | 6050544530660505445306 | 60 TABLET in 1 BOTTLE (60505-4453-6)Marketed from Oct 31, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 60 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208584
- 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 60505-4453_f2be1b4e-a037-f1e5-59b4-a9edced58443SPL ID f2be1b4e-a037-f1e5-59b4-a9edced58443SPL set ID 2c59ea45-6113-6e9e-70b5-3b8c8b3d89b6RxCUI 1116635, 1666332UNII GLH0314RVCUPC 0360505445264
- 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
N460505445306followed by a unit qualifier and the quantityPackage 60505-4453-06. 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 tablets are 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 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 reduc…
Excerpt only. Read the full label for complete information.
About NDC 60505-4453
- What is NDC 60505-4453?
- 60505-4453 is the product NDC for Ticagrelor, Ticagrelor 60 mg/1 tablet, listed with the FDA by Apotex Corp.. 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?
- Apotex Corp., NDC labeler code 60505. 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?
- 53 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 90 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-263 | 42571-0263-0542571-0263-1042571-0263-11+2 more |
| Ticagrelorticagrelore | Ticagrelor 60 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-293 | 42571-0293-0542571-0293-1142571-0293-60 |
| 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 |
Other NDCs under ANDA 208584
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 90 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-861 |
| Ticagrelor | Ticagrelor 90 mg/1 | TabletOral | Apotex Corp. | 60505-4452 |
| Ticagrelor | Ticagrelor 90 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-958 |