Prescription drug · NDA
Brilinta (Ticagrelor) NDC 71610-815
Ticagrelor 90 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-815-41 | 71610081541 | 5400 TABLET in 1 BOTTLE (71610-815-41)Marketed from Apr 3, 2024 |
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)
- Brilinta
- Generic name (nonproprietary)
- ticagrelor
- Active ingredients
- Ticagrelor — 90 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022433
- 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 71610-815_159d6ad1-edcf-d4da-e063-6294a90a6adbSPL ID 159d6ad1-edcf-d4da-e063-6294a90a6adbSPL set ID 1547e2b6-8858-178e-e063-6394a90abb23RxCUI 1116635, 1116639UNII 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
N471610081541followed by a unit qualifier and the quantityPackage 71610-0815-41. 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)
BRILINTA 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. BRILINTA 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 BRILINTA was established in a population with type 2 diabetes mellitus (T2DM). (1.2) to reduce the risk of stroke in patients…
Excerpt only. Read the full label for complete information.
About NDC 71610-815
- What is NDC 71610-815?
- 71610-815 is the product NDC for Brilinta (ticagrelor), Ticagrelor 90 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brilinta (Ticagrelor).
- What is the active ingredient?
- Ticagrelor.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brilinta?
- 3 other product NDCs are listed under this name. See all Brilinta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Brilinta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Brilintaticagrelor | Ticagrelor 60 mg/1 | TabletOral | AstraZeneca Pharmaceuticals LP | 0186-0776 | 00186-0776-60 |
| Brilintaticagrelor | Ticagrelor 90 mg/1 | TabletOral | AstraZeneca Pharmaceuticals LP | 0186-0777 | 00186-0777-3900186-0777-60 |
| Brilintaticagrelor | Ticagrelor 90 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-9618 | 55154-9618-0055154-9618-08 |
Other NDCs under NDA 022433
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 |
|---|---|---|---|---|
| Brilintaticagrelor | Ticagrelor 60 mg/1 | TabletOral | AstraZeneca Pharmaceuticals LP | 0186-0776 |
| Brilintaticagrelor | Ticagrelor 90 mg/1 | TabletOral | AstraZeneca Pharmaceuticals LP | 0186-0777 |
| Brilintaticagrelor | Ticagrelor 90 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-9618 |