Prescription drug · ANDA
Ticagrelor NDC 43547-657
Ticagrelor 90 mg/1 · Tablet, Film coated · Oral · Solco Healthcare U.S., LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-657-06 | 43547065706 | 60 TABLET, FILM COATED in 1 BOTTLE (43547-657-06)Marketed from Apr 1, 2025 | |
| 43547-657-18 | 43547065718 | 180 TABLET, FILM COATED in 1 BOTTLE (43547-657-18)Marketed from Apr 1, 2025 | |
| 43547-657-50 | 43547065750 | 500 TABLET, FILM COATED in 1 BOTTLE (43547-657-50)Marketed from Apr 1, 2025 |
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, Film coated
- Route
- Oral
- Labeler
- Solco Healthcare U.S., LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208599
- 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 43547-657_d51fdfca-5940-4b3c-bfa2-003b208b9309SPL ID d51fdfca-5940-4b3c-bfa2-003b208b9309SPL set ID 5be5ef20-fc9f-4c3b-a482-83ffd8a3ab47RxCUI 1116635UNII GLH0314RVCUPC 0343547657062
- 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
N443547065706followed by a unit qualifier and the quantityPackage 43547-0657-06. 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 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 stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). ( 1.3 ) 1.1 Acute Coronary Syndrome or a History of Myocardial Infarction Ticagrelor is indicated to reduce the risk of cardiovascular (CV) deat…
Excerpt only. Read the full label for complete information.
About NDC 43547-657
- What is NDC 43547-657?
- 43547-657 is the product NDC for Ticagrelor, Ticagrelor 90 mg/1 tablet, film coated, listed with the FDA by Solco Healthcare U.S., LLC. It has 3 package NDCs, 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?
- Solco Healthcare U.S., LLC, NDC labeler code 43547. 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 90 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-941 | 72603-0941-0172603-0941-02 |
| Ticagrelor | Ticagrelor 60 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-940 | 72603-0940-01 |
| Ticagrelor | Ticagrelor 90 mg/1 | TabletOral | AiPing Pharmaceutical, Inc | 11788-158 | 11788-0158-0111788-0158-60 |
| Ticagrelor | Ticagrelor 60 mg/1 | TabletOral | AiPing Pharmaceutical, Inc | 11788-157 | 11788-0157-60 |
| 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 |