Prescription drug · ANDA
ticagrelor NDC 50228-522
Ticagrelor 90 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-522-10 | 5022805221050228052210 | 1000 TABLET in 1 BOTTLE (50228-522-10)Marketed from Oct 9, 2025 | |
| 50228-522-30 | 5022805223050228052230 | 30 TABLET in 1 BOTTLE (50228-522-30)Marketed from Oct 9, 2025 | |
| 50228-522-60 | 5022805226050228052260 | 60 TABLET in 1 BOTTLE (50228-522-60)Marketed from Oct 9, 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
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals INCNDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218962
- 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 50228-522_4a689c1b-28bb-4a83-a32e-5044ade6d7b2SPL ID 4a689c1b-28bb-4a83-a32e-5044ade6d7b2SPL set ID 40ac26dc-2570-de7e-e063-6294a90ade72RxCUI 1116635, 1666332UNII GLH0314RVCUPC 0350228521109, 0350228521604, 0350228521307, 0350228522601, 0350228522106, 0350228522304
- 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
N450228052210followed by a unit qualifier and the quantityPackage 50228-0522-10. 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 50228-522
- What is NDC 50228-522?
- 50228-522 is the product NDC for ticagrelor, Ticagrelor 90 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals INC. 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?
- ScieGen Pharmaceuticals INC, NDC labeler code 50228. 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 218962
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 | ScieGen Pharmaceuticals INC | 50228-521 |
| ticagrelor | Ticagrelor 60 mg/1 | TabletOral | Radha Pharmaceuticals INC | 77771-521 |
| ticagrelor | Ticagrelor 90 mg/1 | TabletOral | Radha Pharmaceuticals INC | 77771-522 |