Irbesartan NDC 42658-122

NDC codes

FDA NDC Directory

Product NDC (as listed)42658-122Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42658-0122Add 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
42658-122-01	42658012201	30 TABLET, FILM COATED in 1 BOTTLE (42658-122-01)Marketed from Apr 15, 2017
42658-122-04	42658012204	90 TABLET, FILM COATED in 1 BOTTLE (42658-122-04)Marketed from Apr 15, 2017
42658-122-07	42658012207	500 TABLET, FILM COATED in 1 BOTTLE (42658-122-07)Marketed from Apr 15, 2017

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 — 150 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Hisun Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206194
Marketing start: Apr 15, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 42658-122_5844e955-a63d-6fb4-e063-6294a90a3caaSPL ID 5844e955-a63d-6fb4-e063-6294a90a3caaSPL set ID 61ab1b6e-c849-49ca-a3f0-150774db649dRxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0342658122018, 0342658121011, 0342658123015
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

N442658012201 followed by a unit qualifier and the quantity

Package 42658-0122-01. 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 Aug 5, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

1.1 Hypertension Irbesartan tablets, USP 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 trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206194

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

FDA NDC Directory listings under ANDA 206194
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan	Irbesartan 75 mg/1	Tablet, Film coatedOral	Hisun Pharmaceuticals USA Inc.	42658-121
Irbesartan	Irbesartan 300 mg/1	Tablet, Film coatedOral	Hisun Pharmaceuticals USA Inc.	42658-123