What is NDC 65162-286?

65162-286 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, 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 Irbesartan?

79 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Irbesartan NDC 65162-286 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-286Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0286Add 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
65162-286-03	65162028603	30 TABLET in 1 BOTTLE (65162-286-03)Marketed from Apr 17, 2018
65162-286-09	65162028609	90 TABLET in 1 BOTTLE (65162-286-09)Marketed from Apr 17, 2018
65162-286-11	65162028611	1000 TABLET in 1 BOTTLE (65162-286-11)Marketed from Apr 17, 2018
65162-286-50	65162028650	500 TABLET in 1 BOTTLE (65162-286-50)Marketed from Apr 17, 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): Irbesartan
Generic name (nonproprietary): irbesartan
Active ingredients: Irbesartan — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204740
Marketing start: Apr 17, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-286_5d575575-9dee-4d65-962c-ca26b26ff85bSPL ID 5d575575-9dee-4d65-962c-ca26b26ff85bSPL set ID 8c9bb449-6341-4f24-9d38-6ca952e07122RxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0365162284034, 0365162285031, 0365162286038
Pharmacologic class: Angiotensin 2 Receptor Blocker

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

N465162028603 followed by a unit qualifier and the quantity

Package 65162-0286-03. 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 Nov 13, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Irbesartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled tri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-286

What is NDC 65162-286?: 65162-286 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Irbesartan.
What is the active ingredient?: Irbesartan.
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 Irbesartan?: 79 other product NDCs are listed under this name. See all Irbesartan 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 Irbesartan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Irbesartan	Irbesartan 75 mg/1	TabletOral	NorthStar RxLLC	72603-670	72603-0670-01
Irbesartan	Irbesartan 150 mg/1	TabletOral	NorthStar RxLLC	72603-671	72603-0671-01
Irbesartan	Irbesartan 300 mg/1	TabletOral	NorthStar RxLLC	72603-672	72603-0672-0172603-0672-02
Irbesartan	Irbesartan 75 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-327	72205-0327-0572205-0327-0672205-0327-30+2 more
Irbesartan	Irbesartan 150 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-328	72205-0328-0572205-0328-0672205-0328-10+3 more
Irbesartan	Irbesartan 300 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-329	72205-0329-0572205-0329-0672205-0329-30+2 more
Irbesartan	Irbesartan 75 mg/1	TabletOral	AvKARE	42291-940	42291-0940-90
Irbesartan	Irbesartan 150 mg/1	TabletOral	AvKARE	42291-941	42291-0941-90
Irbesartan	Irbesartan 300 mg/1	TabletOral	AvKARE	42291-942	42291-0942-90
Irbesartan	Irbesartan 150 mg/1	TabletOral	Quality Care Products, LLC	83008-084	83008-0084-30

All 80 Irbesartan NDCs

Other NDCs under ANDA 204740

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

FDA NDC Directory listings under ANDA 204740
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan	Irbesartan 75 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-284
Irbesartan	Irbesartan 150 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-285