NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1244Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1244Add 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
71335-1244-1713351244017133512440130 TABLET in 1 BOTTLE (71335-1244-1)Marketed from Jun 14, 2019
71335-1244-2713351244027133512440260 TABLET in 1 BOTTLE (71335-1244-2)Marketed from Jun 14, 2019
71335-1244-3713351244037133512440390 TABLET in 1 BOTTLE (71335-1244-3)Marketed from Jun 14, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 150 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202910
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 71335-1244_5e412d17-3dc4-4db6-a9fe-c139a289cd58SPL ID 5e412d17-3dc4-4db6-a9fe-c139a289cd58SPL set ID 7e0ddb7b-80c5-47ab-afee-c74bb735e829RxCUI 200094, 200095UNII J0E2756Z7N

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

N471335124401 followed by a unit qualifier and the quantity

Package 71335-1244-01. 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 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 t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1244

What is NDC 71335-1244?
71335-1244 is the product NDC for Irbesartan, Irbesartan 150 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IrbesartanIrbesartan 75 mg/1TabletOralNorthStar RxLLC72603-67072603-0670-01
IrbesartanIrbesartan 150 mg/1TabletOralNorthStar RxLLC72603-67172603-0671-01
IrbesartanIrbesartan 300 mg/1TabletOralNorthStar RxLLC72603-67272603-0672-0172603-0672-02
IrbesartanIrbesartan 75 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-32772205-0327-0572205-0327-0672205-0327-30+2 more
IrbesartanIrbesartan 150 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-32872205-0328-0572205-0328-0672205-0328-10+3 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 78 Irbesartan NDCs

Other NDCs under ANDA 202910

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

FDA NDC Directory listings under ANDA 202910
ProductStrengthForm · routeLabelerProduct NDC
IrbesartanIrbesartan 75 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-729
IrbesartanIrbesartan 150 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-730
IrbesartanIrbesartan 300 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-731
IrbesartanIrbesartan 150 mg/1TabletOralA-S Medication Solutions50090-1284
IrbesartanIrbesartan 300 mg/1TabletOralA-S Medication Solutions50090-2017
IrbesartanIrbesartan 300 mg/1TabletOralA-S Medication Solutions50090-6938
IrbesartanIrbesartan 150 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8670
IrbesartanIrbesartan 150 mg/1TabletOralREMEDYREPACK INC.70518-2245
IrbesartanIrbesartan 300 mg/1TabletOralREMEDYREPACK INC.70518-2246
IrbesartanIrbesartan 75 mg/1TabletOralREMEDYREPACK INC.70518-2685
IrbesartanIrbesartan 150 mg/1TabletOralProficient Rx LP71205-452
IrbesartanIrbesartan 75 mg/1TabletOralBryant Ranch Prepack71335-1547
IrbesartanIrbesartan 300 mg/1TabletOralBryant Ranch Prepack71335-1826
IrbesartanIrbesartan 150 mg/1TabletOralBryant Ranch Prepack72162-2354
IrbesartanIrbesartan 75 mg/1TabletOraldirect rx72189-201
IrbesartanIrbesartan 150 mg/1TabletOraldirect rx72189-205
IrbesartanIrbesartan 300 mg/1TabletOraldirect rx72189-270
IrbesartanIrbesartan 150 mg/1TabletOralQuality Care Products, LLC83008-084
IrbesartanIrbesartan 75 mg/1TabletOralQuality Care Products, LLC83008-085

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