What is NDC 71335-0071?

71335-0071 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-0071 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0071Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0071Add 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
71335-0071-1	71335007101	30 TABLET in 1 BOTTLE (71335-0071-1)Marketed from Dec 27, 2021
71335-0071-2	71335007102	90 TABLET in 1 BOTTLE (71335-0071-2)Marketed from Dec 27, 2021
71335-0071-3	71335007103	28 TABLET in 1 BOTTLE (71335-0071-3)Marketed from Dec 27, 2021
71335-0071-4	71335007104	60 TABLET in 1 BOTTLE (71335-0071-4)Marketed from Dec 27, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203071
Marketing start: Jun 13, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 71335-0071_44563b18-6fe8-47e2-93bd-9a326eaf9382SPL ID 44563b18-6fe8-47e2-93bd-9a326eaf9382SPL set ID efcd5f2e-1837-44ae-bc91-410c4d8b27c7RxCUI 200096UNII J0E2756Z7N
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

N471335007101 followed by a unit qualifier and the quantity

Package 71335-0071-01. 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 Nov 27, 2023. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0071

What is NDC 71335-0071?: 71335-0071 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 203071

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

FDA NDC Directory listings under ANDA 203071
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan	Irbesartan 75 mg/1	TabletOral	Solco Healthcare U.S., LLC	43547-374
Irbesartan	Irbesartan 150 mg/1	TabletOral	Solco Healthcare U.S., LLC	43547-375
Irbesartan	Irbesartan 300 mg/1	TabletOral	Solco Healthcare U.S., LLC	43547-376
Irbesartan	Irbesartan 300 mg/1	TabletOral	A-S Medication Solutions	50090-2978
Irbesartan	Irbesartan 300 mg/1	TabletOral	A-S Medication Solutions	50090-7622
Irbesartan	Irbesartan 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-1543
Irbesartan	Irbesartan 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-1690
Irbesartan	Irbesartan 150 mg/1	TabletOral	Proficient Rx LP	71205-082
Irbesartan	Irbesartan 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-2168
Irbesartan	Irbesartan 75 mg/1	TabletOral	Bryant Ranch Prepack	71335-2745
Irbesartan	Irbesartan 150 mg/1	TabletOral	Bryant Ranch Prepack	72162-2355