Prescription drug · ANDA
Ticagrelor (Ticagrelore) NDC 42571-293
Ticagrelor 60 mg/1 · Tablet, Film coated · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-293-05 | 4257102930542571029305 | 500 TABLET, FILM COATED in 1 BOTTLE (42571-293-05)Marketed from Nov 1, 2026 | |
| 42571-293-11 | 4257102931142571029311 | 100 TABLET, FILM COATED in 1 CARTON (42571-293-11)Marketed from Nov 1, 2026 | |
| 42571-293-60 | 4257102936042571029360 | 60 TABLET, FILM COATED in 1 BOTTLE (42571-293-60)Marketed from Nov 1, 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)
- ticagrelore
- Active ingredients
- Ticagrelor — 60 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208539
- 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 42571-293_58c2e103-8f0a-c4e1-e063-6294a90a2260SPL ID 58c2e103-8f0a-c4e1-e063-6294a90a2260SPL set ID 2861af6a-7449-4686-bf0d-5f9c2db07631UNII GLH0314RVCUPC 0342571293604, 0342571263607
- 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
N442571029305followed by a unit qualifier and the quantityPackage 42571-0293-05. 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)
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 was established in a population with type 2 diabetes mellitus (T2DM). ( 1.2 ) to re…
Excerpt only. Read the full label for complete information.
About NDC 42571-293
- What is NDC 42571-293?
- 42571-293 is the product NDC for Ticagrelor (ticagrelore), Ticagrelor 60 mg/1 tablet, film coated, listed with the FDA by Micro Labs Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ticagrelor (Ticagrelore).
- What is the active ingredient?
- Ticagrelor.
- Who is the labeler?
- Micro Labs Limited, NDC labeler code 42571. 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 |
| 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 |
Other NDCs under ANDA 208539
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 | Tablet, Film coatedOral | Micro Labs Limited | 42571-263 |