NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8259Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8259Add 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
63629-8259-1636298259016362982590130 TABLET in 1 BOTTLE (63629-8259-1)Marketed from Feb 9, 2022
63629-8259-2636298259026362982590290 TABLET in 1 BOTTLE (63629-8259-2)Marketed from Feb 9, 2022

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 — 75 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202254
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63629-8259_0792cf42-f3a7-4419-8764-676484921763SPL ID 0792cf42-f3a7-4419-8764-676484921763

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

N463629825901 followed by a unit qualifier and the quantity

Package 63629-8259-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 63629-8259

What is NDC 63629-8259?
63629-8259 is the product NDC for Irbesartan, Irbesartan 75 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 2 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 63629. 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 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
ProductStrengthForm · routeLabelerProduct NDC
IrbesartanIrbesartan 75 mg/1TabletOralMacleods Pharmaceuticals Limited33342-047
IrbesartanIrbesartan 150 mg/1TabletOralMacleods Pharmaceuticals Limited33342-048
IrbesartanIrbesartan 300 mg/1TabletOralMacleods Pharmaceuticals Limited33342-049
IrbesartanIrbesartan 150 mg/1TabletOralProficient Rx LP63187-737
IrbesartanIrbesartan 300 mg/1TabletOralBryant Ranch Prepack63629-5241
IrbesartanIrbesartan 75 mg/1TabletOralProficient Rx LP71205-379
IrbesartanIrbesartan 150 mg/1TabletOralBryant Ranch Prepack71335-1263
IrbesartanIrbesartan 75 mg/1TabletOralNorthStar RxLLC72603-670
IrbesartanIrbesartan 150 mg/1TabletOralNorthStar RxLLC72603-671
IrbesartanIrbesartan 300 mg/1TabletOralNorthStar RxLLC72603-672

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in