NDC codes

FDA NDC Directory
Product NDC (as listed)62332-043Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0043Add 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
62332-043-306233200433030 TABLET in 1 BOTTLE (62332-043-30)Marketed from Jul 1, 2016
62332-043-3162332004331100 TABLET in 1 BOTTLE (62332-043-31)Marketed from Jul 1, 2016
62332-043-7162332004371500 TABLET in 1 BOTTLE (62332-043-71)Marketed from Jul 1, 2016
62332-043-906233200439090 TABLET in 1 BOTTLE (62332-043-90)Marketed from Jul 1, 2016
62332-043-91623320043911000 TABLET in 1 BOTTLE (62332-043-91)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 Inc.NDC labeler code 62332
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091236
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 62332-043_e21c14f4-6c8c-4676-b479-dff181ec3fa1SPL ID e21c14f4-6c8c-4676-b479-dff181ec3fa1SPL set ID 83f5d5c8-27c0-4208-a291-0c4aa55a1ff5RxCUI 200094, 200095, 200096UNII J0E2756Z7NUPC 0362332042302, 0362332041305, 0362332043309

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

N462332004330 followed by a unit qualifier and the quantity

Package 62332-0043-30. 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 . 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 tri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62332-043

What is NDC 62332-043?
62332-043 is the product NDC for Irbesartan, Irbesartan 300 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Inc.. 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 Inc., NDC labeler code 62332. 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 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
ProductStrengthForm · routeLabelerProduct NDC
IrbesartanIrbesartan 150 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-042
IrbesartanIrbesartan 75 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-041
IrbesartanIrbesartan 75 mg/1TabletOralAlembic Pharmaceuticals Limited46708-439
IrbesartanIrbesartan 150 mg/1TabletOralAlembic Pharmaceuticals Limited46708-440
IrbesartanIrbesartan 300 mg/1TabletOralAlembic Pharmaceuticals Limited46708-441

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