Ticagrelor NDC 0378-2214

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-2214Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-2214Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-2214-91	00378221491	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2214-91)Marketed from Sep 25, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208597
Marketing start: Sep 25, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 3A4 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P-Glycoprotein Inhibitors (Mechanism)P2Y12 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0378-2214_fc333c4a-ad63-4d67-a3f7-431ac469d116SPL ID fc333c4a-ad63-4d67-a3f7-431ac469d116SPL set ID fc333c4a-ad63-4d67-a3f7-431ac469d116RxCUI 1116635, 1666332UNII GLH0314RVCUPC 0303782215915
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

N400378221491 followed by a unit qualifier and the quantity

Package 00378-2214-91. 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 Apr 14, 2025. 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 reduce 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 ) • …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208597

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208597
Product	Strength	Form · route	Labeler	Product NDC
Ticagrelor	Ticagrelor 90 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-2215