What is NDC 68180-412?

68180-412 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..

Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 68180-412 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-412Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0412Add the package segment from the table below.

Product information

Brand name (proprietary): Irbesartan
Generic name (nonproprietary): irbesartan
Active ingredients: Irbesartan — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201531
Marketing start: Oct 23, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68180-412_22c8bdba-6c34-485a-af89-3aafd7fd8605SPL ID 22c8bdba-6c34-485a-af89-3aafd7fd8605SPL set ID a7c093c2-3eef-4956-8a14-c36aada0304fRxCUI 200094, 200095, 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.

Product label

Current FDA label (SPL), effective Nov 22, 2023. 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 trial…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-412

What is NDC 68180-412?: 68180-412 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..
What drug is associated with this NDC?: Irbesartan.
What is the active ingredient?: Irbesartan.
Who is the labeler?: Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 201531

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

FDA NDC Directory listings under ANDA 201531
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan	Irbesartan 150 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-411