NDC codes

FDA NDC Directory
Product NDC (as listed)43547-617Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0617Add 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
43547-617-034354706170330 TABLET in 1 BOTTLE (43547-617-03)Marketed from Jul 5, 2022
43547-617-1043547061710100 TABLET in 1 BOTTLE (43547-617-10)Marketed from Jul 5, 2022
43547-617-5043547061750500 TABLET in 1 BOTTLE (43547-617-50)Marketed from Jul 5, 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)
Bisoprolol fumarate
Generic name (nonproprietary)
bisoprolol fumarate
Active ingredients
Bisoprolol fumarate10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217368
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 43547-617_e8b6cea1-8a7f-4255-8a24-ff96d6ceece2SPL ID e8b6cea1-8a7f-4255-8a24-ff96d6ceece2SPL set ID 084308e4-3b8b-40d6-acbf-d775772a8a73RxCUI 854901, 854905UNII UR59KN573LUPC 0343547616038, 0343547617035
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

N443547061703 followed by a unit qualifier and the quantity

Package 43547-0617-03. 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)

INDICATIONS AND USAGE Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217368

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

FDA NDC Directory listings under ANDA 217368
ProductStrengthForm · routeLabelerProduct NDC
Bisoprolol fumarateBisoprolol fumarate 5 mg/1TabletOralSolco Healthcare US, LLC43547-616

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