NDC codes

FDA NDC Directory
Product NDC (as listed)43547-527Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0527Add 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
43547-527-03435470527034354705270330 TABLET in 1 BOTTLE (43547-527-03)Marketed from Feb 14, 2022
43547-527-09435470527094354705270990 TABLET in 1 BOTTLE (43547-527-09)Marketed from Feb 14, 2022
43547-527-504354705275043547052750500 TABLET in 1 BOTTLE (43547-527-50)Marketed from Feb 14, 2022

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 — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Solco Healthcare US, LLCNDC labeler code 43547
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212682
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 43547-527_1de49f6d-b50a-4f6e-8f74-5db50d836a33SPL ID 1de49f6d-b50a-4f6e-8f74-5db50d836a33SPL set ID 51d3f12f-94cc-4f58-94d3-61990e16adfcRxCUI 387013, 751612, 751618, 827073UNII 030Y90569UUPC 0343547526030, 0343547524036, 0343547527037, 0343547525033
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

N443547052703 followed by a unit qualifier and the quantity

Package 43547-0527-03. 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 .

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Nebivolol is 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 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-527

What is NDC 43547-527?
43547-527 is the product NDC for Nebivolol, Nebivolol 20 mg/1 tablet, listed with the FDA by Solco Healthcare US, LLC. 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.
Who is the labeler?
Solco Healthcare US, LLC, NDC labeler code 43547. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NebivololNebivolol 20 mg/1TabletOralMajor Pharmaceuticals0904-750000904-7500-04
NebivololNebivolol hydrochloride 5 mg/1TabletOralREMEDYREPACK INC.70518-464870518-4648-00
NebivololNebivolol hydrochloride 2.5 mg/1TabletOralNorthStar RxLLC72603-87072603-0870-01
NebivololNebivolol hydrochloride 5 mg/1TabletOralNorthStar RxLLC72603-87172603-0871-0172603-0871-02
NebivololNebivolol hydrochloride 10 mg/1TabletOralNorthStar RxLLC72603-87272603-0872-0172603-0872-02
NebivololNebivolol hydrochloride 20 mg/1TabletOralNorthStar RxLLC72603-87372603-0873-0172603-0873-02
NebivololNebivolol 2.5 mg/1TabletOralMajor Pharmaceuticals0904-749700904-7497-04
NebivololNebivolol 5 mg/1TabletOralMajor Pharmaceuticals0904-749800904-7498-04
NebivololNebivolol 10 mg/1TabletOralMajor Pharmaceuticals0904-749900904-7499-04
NebivololNebivolol hydrochloride 2.5 mg/1TabletOralMacleods Pharmaceuticals Limited33342-45733342-0457-0733342-0457-1033342-0457-25

All 90 Nebivolol NDCs

Other NDCs under ANDA 212682

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

FDA NDC Directory listings under ANDA 212682
ProductStrengthForm · routeLabelerProduct NDC
NebivololNebivolol 2.5 mg/1TabletOralMajor Pharmaceuticals0904-7497
NebivololNebivolol 5 mg/1TabletOralMajor Pharmaceuticals0904-7498
NebivololNebivolol 10 mg/1TabletOralMajor Pharmaceuticals0904-7499
NebivololNebivolol 20 mg/1TabletOralMajor Pharmaceuticals0904-7500
NebivololNebivolol 2.5 mg/1TabletOralSolco Healthcare US, LLC43547-524
NebivololNebivolol 5 mg/1TabletOralSolco Healthcare US, LLC43547-525
NebivololNebivolol 10 mg/1TabletOralSolco Healthcare US, LLC43547-526
NebivololnebibololNebivolol 10 mg/1TabletOralA-S Medication Solutions50090-7185
NebivololNebivolol 20 mg/1TabletOralA-S Medication Solutions50090-7301
NebivololNebivolol 5 mg/1TabletOralBryant Ranch Prepack63629-9589
NebivololNebivolol 5 mg/1TabletOralREMEDYREPACK INC.70518-4032
NebivololnebibololNebivolol 10 mg/1TabletOralBryant Ranch Prepack71335-2443
NebivololNebivolol 5 mg/1TabletOralBryant Ranch Prepack71335-2516
NebivololNebivolol 20 mg/1TabletOralDirect_Rx72189-592

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