What is NDC 33342-460?

33342-460 is the product NDC for Nebivolol, Nebivolol hydrochloride 20 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nebivolol?

89 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nebivolol NDC 33342-460 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-460Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0460Add 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
33342-460-07	3334204600733342046007	30 TABLET in 1 BOTTLE (33342-460-07)Marketed from Jan 29, 2025
33342-460-10	3334204601033342046010	90 TABLET in 1 BOTTLE (33342-460-10)Marketed from Jan 29, 2025
33342-460-25	3334204602533342046025	12 BLISTER PACK in 1 CARTON (33342-460-25) / 10 TABLET in 1 BLISTER PACKMarketed from Jan 29, 2025

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): Nebivolol
Generic name (nonproprietary): nebivolol
Active ingredients: Nebivolol hydrochloride — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212661
Marketing start: Jan 29, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 33342-460_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0eSPL ID b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0eSPL set ID b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0eRxCUI 387013, 751612, 751618, 827073UNII JGS34J7L9IUPC 0333342458070, 0333342459077, 0333342460073, 0333342457073
Pharmacologic class: beta-Adrenergic 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

N433342046007 followed by a unit qualifier and the quantity

Package 33342-0460-07. 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 Apr 8, 2025.

Indications (excerpt from the label)

Nebivolol tablets are a beta-adrenergic blocking agent indicated for the 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 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )]. Nebivolol tablets may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlle…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-460

What is NDC 33342-460?: 33342-460 is the product NDC for Nebivolol, Nebivolol hydrochloride 20 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nebivolol.
What is the active ingredient?: Nebivolol hydrochloride.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nebivolol?: 89 other product NDCs are listed under this name. See all Nebivolol 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 Nebivolol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nebivolol	Nebivolol 20 mg/1	TabletOral	Major Pharmaceuticals	0904-7500	00904-7500-04
Nebivolol	Nebivolol hydrochloride 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4648	70518-4648-00
Nebivolol	Nebivolol hydrochloride 2.5 mg/1	TabletOral	NorthStar RxLLC	72603-870	72603-0870-01
Nebivolol	Nebivolol hydrochloride 5 mg/1	TabletOral	NorthStar RxLLC	72603-871	72603-0871-0172603-0871-02
Nebivolol	Nebivolol hydrochloride 10 mg/1	TabletOral	NorthStar RxLLC	72603-872	72603-0872-0172603-0872-02
Nebivolol	Nebivolol hydrochloride 20 mg/1	TabletOral	NorthStar RxLLC	72603-873	72603-0873-0172603-0873-02
Nebivolol	Nebivolol 2.5 mg/1	TabletOral	Major Pharmaceuticals	0904-7497	00904-7497-04
Nebivolol	Nebivolol 5 mg/1	TabletOral	Major Pharmaceuticals	0904-7498	00904-7498-04
Nebivolol	Nebivolol 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7499	00904-7499-04
Nebivolol	Nebivolol hydrochloride 2.5 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-457	33342-0457-0733342-0457-1033342-0457-25

All 90 Nebivolol NDCs

Other NDCs under ANDA 212661

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

FDA NDC Directory listings under ANDA 212661
Product	Strength	Form · route	Labeler	Product NDC
Nebivolol	Nebivolol hydrochloride 2.5 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-457
Nebivolol	Nebivolol hydrochloride 5 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-458
Nebivolol	Nebivolol hydrochloride 10 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-459
Nebivolol	Nebivolol hydrochloride 2.5 mg/1	TabletOral	NorthStar RxLLC	72603-870
Nebivolol	Nebivolol hydrochloride 5 mg/1	TabletOral	NorthStar RxLLC	72603-871
Nebivolol	Nebivolol hydrochloride 10 mg/1	TabletOral	NorthStar RxLLC	72603-872
Nebivolol	Nebivolol hydrochloride 20 mg/1	TabletOral	NorthStar RxLLC	72603-873