Irbesartan NDC 65862-639

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-639Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0639Add 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
65862-639-05	65862063905	500 TABLET in 1 BOTTLE (65862-639-05)Marketed from Sep 27, 2012
65862-639-30	65862063930	30 TABLET in 1 BOTTLE (65862-639-30)Marketed from Sep 27, 2012
65862-639-78	65862063978	10 BLISTER PACK in 1 CARTON (65862-639-78) / 10 TABLET in 1 BLISTER PACK (65862-639-10)Marketed from Sep 22, 2014
65862-639-90	65862063990	90 TABLET in 1 BOTTLE (65862-639-90)Marketed from Sep 27, 2012

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: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203081
Marketing start: Sep 27, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65862-639_9e17df53-3757-4012-a76f-d1aa0053fda0SPL ID 9e17df53-3757-4012-a76f-d1aa0053fda0SPL set ID 2113a901-2612-4557-b86d-3afc006fb8bbRxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0365862637901
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

N465862063905 followed by a unit qualifier and the quantity

Package 65862-0639-05. 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 21, 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)

Other NDCs under ANDA 203081

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

FDA NDC Directory listings under ANDA 203081
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan	Irbesartan 75 mg/1	TabletOral	Aurobindo Pharma Limited	65862-637
Irbesartan	Irbesartan 150 mg/1	TabletOral	Aurobindo Pharma Limited	65862-638