What is NDC 83008-085?

83008-085 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Quality Care Products, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Quality Care Products, LLC, NDC labeler code 83008. 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?

77 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 83008-085 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83008-085Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83008-0085Add 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
83008-085-30	8300800853083008008530	30 TABLET in 1 BOTTLE (83008-085-30)Marketed from Aug 28, 2024

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 — 75 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Quality Care Products, LLCNDC labeler code 83008
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202910
Marketing start: Aug 28, 2024
Marketing end: Feb 28, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 83008-085_e5af9766-e94f-4240-b3ff-2565a89ba702SPL ID e5af9766-e94f-4240-b3ff-2565a89ba702SPL set ID 9b8581c1-d052-4fe2-a9fc-cf7adf0f9061RxCUI 200094, 200095UNII 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

N483008008530 followed by a unit qualifier and the quantity

Package 83008-0085-30. 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 Dec 19, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Irbesartan tablet is 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 t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83008-085

What is NDC 83008-085?: 83008-085 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Quality Care Products, LLC. It has 1 package NDC, 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?: Quality Care Products, LLC, NDC labeler code 83008. 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?: 77 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 78 Irbesartan NDCs

Other NDCs under ANDA 202910

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

FDA NDC Directory listings under ANDA 202910
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan	Irbesartan 75 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-729
Irbesartan	Irbesartan 150 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-730
Irbesartan	Irbesartan 300 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-731
Irbesartan	Irbesartan 150 mg/1	TabletOral	A-S Medication Solutions	50090-1284
Irbesartan	Irbesartan 300 mg/1	TabletOral	A-S Medication Solutions	50090-2017
Irbesartan	Irbesartan 300 mg/1	TabletOral	A-S Medication Solutions	50090-6938
Irbesartan	Irbesartan 150 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8670
Irbesartan	Irbesartan 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-2245
Irbesartan	Irbesartan 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-2246
Irbesartan	Irbesartan 75 mg/1	TabletOral	REMEDYREPACK INC.	70518-2685
Irbesartan	Irbesartan 150 mg/1	TabletOral	Proficient Rx LP	71205-452
Irbesartan	Irbesartan 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-1244
Irbesartan	Irbesartan 75 mg/1	TabletOral	Bryant Ranch Prepack	71335-1547
Irbesartan	Irbesartan 300 mg/1	TabletOral	Bryant Ranch Prepack	71335-1826
Irbesartan	Irbesartan 150 mg/1	TabletOral	Bryant Ranch Prepack	72162-2354
Irbesartan	Irbesartan 75 mg/1	TabletOral	direct rx	72189-201
Irbesartan	Irbesartan 150 mg/1	TabletOral	direct rx	72189-205
Irbesartan	Irbesartan 300 mg/1	TabletOral	direct rx	72189-270
Irbesartan	Irbesartan 150 mg/1	TabletOral	Quality Care Products, LLC	83008-084