What is NDC 43547-374?

43547-374 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Solco Healthcare U.S., LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Solco Healthcare U.S., LLC, NDC labeler code 43547. 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 43547-374 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-374Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0374Add 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
43547-374-03	43547037403	30 TABLET in 1 BOTTLE (43547-374-03)Marketed from Jun 13, 2016
43547-374-09	43547037409	90 TABLET in 1 BOTTLE (43547-374-09)Marketed from Jun 13, 2016
43547-374-50	43547037450	500 TABLET in 1 BOTTLE (43547-374-50)Marketed from Jun 13, 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 — 75 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare U.S., LLCNDC labeler code 43547
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 43547-374_9dd3ba36-25b6-45da-906f-316049b9f23bSPL ID 9dd3ba36-25b6-45da-906f-316049b9f23bSPL set ID 6916c617-92d2-44f5-b968-6267517a2ce6RxCUI 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.

NDC on a medical claim

N443547037403 followed by a unit qualifier and the quantity

Package 43547-0374-03. 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 Sep 30, 2025. 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 t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-374

What is NDC 43547-374?: 43547-374 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Solco Healthcare U.S., LLC. It has 3 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?: Solco Healthcare U.S., LLC, NDC labeler code 43547. 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 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 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-2168
Irbesartan	Irbesartan 75 mg/1	TabletOral	Bryant Ranch Prepack	71335-2745
Irbesartan	Irbesartan 300 mg/1	TabletOral	Bryant Ranch Prepack	71335-0071
Irbesartan	Irbesartan 300 mg/1	TabletOral	REMEDYREPACK INC.	70518-1543
Irbesartan	Irbesartan 150 mg/1	TabletOral	Bryant Ranch Prepack	72162-2355
Irbesartan	Irbesartan 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-1690
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 150 mg/1	TabletOral	Proficient Rx LP	71205-082