Ticagrelor NDC 69097-991

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-991Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0991Add 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
69097-991-03	69097099103	60 TABLET, FILM COATED in 1 PACKAGE (69097-991-03)Marketed from May 1, 2025
69097-991-07	69097099107	100 TABLET, FILM COATED in 1 PACKAGE (69097-991-07)Marketed from May 1, 2025
69097-991-12	69097099112	500 TABLET, FILM COATED in 1 PACKAGE (69097-991-12)Marketed from May 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: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208537
Marketing start: May 1, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A4 Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)P-Glycoprotein Inhibitors (Mechanism)P2Y12 Receptor Antagonists (Mechanism)
Identifiers: Product ID 69097-991_d431b0b1-c7f9-40e4-9a30-6e778dcdde8cSPL ID d431b0b1-c7f9-40e4-9a30-6e778dcdde8cSPL set ID 789606e3-9efa-440c-84f1-f1c56fcbf0cdRxCUI 1116635, 1666332UNII GLH0314RVCUPC 0369097989125, 0369097989033, 0369097991128, 0369097991036, 0369097991074, 0369097989071
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

N469097099103 followed by a unit qualifier and the quantity

Package 69097-0991-03. 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 Mar 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE SECTION Ticagrelor tablets are a P2Y12 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 diabete…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208537

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

FDA NDC Directory listings under ANDA 208537
Product	Strength	Form · route	Labeler	Product NDC
Ticagrelor	Ticagrelor 90 mg/1	Tablet, Film coatedOral	Exelan Pharmaceuticals, Inc	76282-550
Ticagrelor	Ticagrelor 60 mg/1	Tablet, Film coatedOral	Exelan Pharmaceuticals, Inc	76282-584
Ticagrelor	Ticagrelor 90 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-914
Ticagrelor	Ticagrelor 60 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-989