What is NDC 33342-047?

33342-047 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 33342-047 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-047Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0047Add 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
33342-047-07	3334200470733342004707	30 TABLET in 1 BOTTLE (33342-047-07)Marketed from Sep 27, 2012
33342-047-10	3334200471033342004710	90 TABLET in 1 BOTTLE (33342-047-10)Marketed from Mar 11, 2013
33342-047-12	3334200471233342004712	10 BLISTER PACK in 1 CARTON (33342-047-12) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 27, 2012
33342-047-15	3334200471533342004715	500 TABLET in 1 BOTTLE (33342-047-15)Marketed from Sep 27, 2012
33342-047-68	3334200476833342004768	13600 TABLET in 1 POUCH (33342-047-68)Marketed from Feb 26, 2019

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: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202254
Marketing start: Sep 27, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 33342-047_5a240405-5eb7-46ca-811b-d8dd93ee43d3SPL ID 5a240405-5eb7-46ca-811b-d8dd93ee43d3SPL set ID e8635a1c-ae06-4e23-99f7-e704f91d6f43RxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0333342049100, 0333342047106, 0333342048103
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

N433342004707 followed by a unit qualifier and the quantity

Package 33342-0047-07. 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 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Irbesartan 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 trials of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-047

What is NDC 33342-047?: 33342-047 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Macleods 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?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 202254

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

FDA NDC Directory listings under ANDA 202254
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan	Irbesartan 150 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-048
Irbesartan	Irbesartan 300 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-049
Irbesartan	Irbesartan 150 mg/1	TabletOral	Proficient Rx LP	63187-737
Irbesartan	Irbesartan 300 mg/1	TabletOral	Bryant Ranch Prepack	63629-5241
Irbesartan	Irbesartan 75 mg/1	TabletOral	Bryant Ranch Prepack	63629-8259
Irbesartan	Irbesartan 75 mg/1	TabletOral	Proficient Rx LP	71205-379
Irbesartan	Irbesartan 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-1263
Irbesartan	Irbesartan 75 mg/1	TabletOral	NorthStar RxLLC	72603-670
Irbesartan	Irbesartan 150 mg/1	TabletOral	NorthStar RxLLC	72603-671
Irbesartan	Irbesartan 300 mg/1	TabletOral	NorthStar RxLLC	72603-672