NDC codes

FDA NDC Directory
Product NDC (as listed)59746-447Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59746-0447Add 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 NDC11-digit (billing)PackageCopy
59746-447-0559746044705500 TABLET in 1 BOTTLE (59746-447-05)Marketed from Feb 24, 2015
59746-447-305974604473030 TABLET in 1 BOTTLE (59746-447-30)Marketed from Feb 24, 2015
59746-447-905974604479090 TABLET in 1 BOTTLE (59746-447-90)Marketed from Feb 24, 2015

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
Jubilant Cadista Pharmaceuticals Inc.NDC labeler code 59746
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203534
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 59746-447_45662cb2-60ef-45d5-80a2-fd60ee7250bdSPL ID 45662cb2-60ef-45d5-80a2-fd60ee7250bdSPL set ID 068224c4-a34d-32d7-bb2a-7eed44ccf7d3RxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0359746447304, 0359746448301, 0359746449308

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

N459746044705 followed by a unit qualifier and the quantity

Package 59746-0447-05. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Irbesartan tablets are 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 59746-447

What is NDC 59746-447?
59746-447 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Jubilant Cadista Pharmaceuticals Inc.. 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?
Jubilant Cadista Pharmaceuticals Inc., NDC labeler code 59746. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IrbesartanIrbesartan 300 mg/1TabletOralNorthStar RxLLC72603-67272603-0672-0172603-0672-02
IrbesartanIrbesartan 75 mg/1TabletOralNorthStar RxLLC72603-67072603-0670-01
IrbesartanIrbesartan 150 mg/1TabletOralNorthStar RxLLC72603-67172603-0671-01
IrbesartanIrbesartan 150 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-32872205-0328-0572205-0328-0672205-0328-10+3 more
IrbesartanIrbesartan 75 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-32772205-0327-0572205-0327-0672205-0327-30+2 more
IrbesartanIrbesartan 300 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-32972205-0329-0572205-0329-0672205-0329-30+2 more
IrbesartanIrbesartan 75 mg/1TabletOralAvKARE42291-94042291-0940-90
IrbesartanIrbesartan 150 mg/1TabletOralAvKARE42291-94142291-0941-90
IrbesartanIrbesartan 300 mg/1TabletOralAvKARE42291-94242291-0942-90
IrbesartanIrbesartan 150 mg/1TabletOralQuality Care Products, LLC83008-08483008-0084-30

All 81 Irbesartan NDCs

Other NDCs under ANDA 203534

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

FDA NDC Directory listings under ANDA 203534
ProductStrengthForm · routeLabelerProduct NDC
IrbesartanIrbesartan 150 mg/1TabletOralAvKARE42291-941
IrbesartanIrbesartan 75 mg/1TabletOralAvKARE42291-940
IrbesartanIrbesartan 300 mg/1TabletOralAvKARE42291-942
IrbesartanIrbesartan 150 mg/1TabletOralJubilant Cadista Pharmaceuticals Inc.59746-448
IrbesartanIrbesartan 300 mg/1TabletOralJubilant Cadista Pharmaceuticals Inc.59746-449

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