What is NDC 46708-441?

46708-441 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?

80 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 46708-441 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-441Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0441Add 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
46708-441-30	46708044130	30 TABLET in 1 BOTTLE (46708-441-30)Marketed from Jul 1, 2016
46708-441-31	46708044131	100 TABLET in 1 BOTTLE (46708-441-31)Marketed from Jul 1, 2016
46708-441-71	46708044171	500 TABLET in 1 BOTTLE (46708-441-71)Marketed from Jul 1, 2016
46708-441-90	46708044190	90 TABLET in 1 BOTTLE (46708-441-90)Marketed from Jul 1, 2016
46708-441-91	46708044191	1000 TABLET in 1 BOTTLE (46708-441-91)Marketed from Jul 1, 2016

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: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091236
Marketing start: Jul 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 46708-441_2efa4733-b806-42ee-b587-cae816493fa7SPL ID 2efa4733-b806-42ee-b587-cae816493fa7SPL set ID 0898f423-0aa9-409c-8d4e-1349b59141d1RxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0346708439309, 0346708441302, 0346708440305
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

N446708044130 followed by a unit qualifier and the quantity

Package 46708-0441-30. 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 Jun 3, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Irbesartan Tablets USP 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 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 contro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-441

What is NDC 46708-441?: 46708-441 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?: 80 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 300 mg/1	TabletOral	NorthStar RxLLC	72603-672	72603-0672-0172603-0672-02
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 150 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-328	72205-0328-0572205-0328-0672205-0328-10+3 more
Irbesartan	Irbesartan 75 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-327	72205-0327-0572205-0327-0672205-0327-30+2 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 81 Irbesartan NDCs

Other NDCs under ANDA 091236

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

FDA NDC Directory listings under ANDA 091236
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan	Irbesartan 150 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-042
Irbesartan	Irbesartan 75 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-041
Irbesartan	Irbesartan 75 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-439
Irbesartan	Irbesartan 300 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-043
Irbesartan	Irbesartan 150 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-440