What is NDC 65162-001?

65162-001 is the product NDC for Prasugrel, Prasugrel hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Prasugrel?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prasugrel NDC 65162-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0001Add 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
65162-001-03	65162000103	30 TABLET, FILM COATED in 1 BOTTLE (65162-001-03)Marketed from Jun 22, 2018

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): Prasugrel
Generic name (nonproprietary): prasugrel
Active ingredients: Prasugrel hydrochloride — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205913
Marketing start: Jun 22, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-001_ae5f7419-c5fe-4462-8f0e-ffc08e891cd0SPL ID ae5f7419-c5fe-4462-8f0e-ffc08e891cd0SPL set ID 406cc201-89b6-43cc-9e14-a59327a5b4d8RxCUI 855812, 855818UNII G89JQ59I13UPC 0365162002034, 0365162001037
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

N465162000103 followed by a unit qualifier and the quantity

Package 65162-0001-03. 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 9, 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 interv…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-001

What is NDC 65162-001?: 65162-001 is the product NDC for Prasugrel, Prasugrel hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Prasugrel.
What is the active ingredient?: Prasugrel hydrochloride.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prasugrel?: 18 other product NDCs are listed under this name. See all Prasugrel NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Prasugrel NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-883	60687-0883-21
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4856	60505-4856-03
Prasugrel	Prasugrel hydrochloride 5 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-301	29300-0301-13
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-302	29300-0302-13
Prasugrel	Prasugrel hydrochloride 5 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-272	16729-0272-10
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-273	16729-0273-10
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-002	65162-0002-03
Prasugrel	Prasugrel hydrochloride 5 mg/1	Tablet, Film coatedOral	Panacea Biotec Limited	43817-239	43817-0239-01
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	Panacea Biotec Limited	43817-240	43817-0240-01
Prasugrel	Prasugrel hydrochloride 5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4642	60505-4642-03

All 19 Prasugrel NDCs

Other NDCs under ANDA 205913

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

FDA NDC Directory listings under ANDA 205913
Product	Strength	Form · route	Labeler	Product NDC
Prasugrel	Prasugrel hydrochloride 10 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-002