Prasugrel NDC 0378-5185

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-5185Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-5185Add 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
0378-5185-93	00378518593	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5185-93)Marketed from Aug 16, 2017

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): Prasugrel
Generic name (nonproprietary): prasugrel
Active ingredients: Prasugrel hydrochloride — 5 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 205927
Marketing start: Aug 16, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0378-5185_9e234352-49b7-46e3-bc59-acf63e0a7a14SPL ID 9e234352-49b7-46e3-bc59-acf63e0a7a14SPL set ID 41a4e332-6725-4cb7-940a-8291cf56cfe4RxCUI 855812, 855818UNII G89JQ59I13UPC 0303785185932
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

N400378518593 followed by a unit qualifier and the quantity

Package 00378-5185-93. 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 Jun 29, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Prasugrel tablets are a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: • Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). • Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI ( 1.1 ). 1.1 Acute Coronary Syndrome Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205927

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

FDA NDC Directory listings under ANDA 205927
Product	Strength	Form · route	Labeler	Product NDC
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5186
Prasugrel	Prasugrel hydrochloride 5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-444
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-445