What is NDC 43547-616?

43547-616 is the product NDC for Bisoprolol fumarate, Bisoprolol fumarate 5 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.

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 Bisoprolol fumarate?

40 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bisoprolol fumarate NDC 43547-616 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0616Add 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
43547-616-03	4354706160343547061603	30 TABLET in 1 BOTTLE (43547-616-03)Marketed from Jul 5, 2022
43547-616-10	4354706161043547061610	100 TABLET in 1 BOTTLE (43547-616-10)Marketed from Jul 5, 2022
43547-616-50	4354706165043547061650	500 TABLET in 1 BOTTLE (43547-616-50)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 fumarate — 5 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 217368
Marketing start: Jul 5, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 43547-616_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

N443547061603 followed by a unit qualifier and the quantity

Package 43547-0616-03. 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 Jun 26, 2023.

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)

About NDC 43547-616

What is NDC 43547-616?: 43547-616 is the product NDC for Bisoprolol fumarate, Bisoprolol fumarate 5 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?: Bisoprolol fumarate.
What is the active ingredient?: Bisoprolol fumarate.
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 Bisoprolol fumarate?: 40 other product NDCs are listed under this name. See all Bisoprolol fumarate 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 Bisoprolol fumarate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bisoprolol Fumarate	Bisoprolol fumarate 5 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-709	64980-0709-0164980-0709-03
Bisoprolol Fumarate	Bisoprolol fumarate 10 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-710	64980-0710-0164980-0710-03
Bisoprolol Fumarate	Bisoprolol fumarate 2.5 mg/1	Tablet, Film coatedOral	TruPharma LLC	52817-268	52817-0268-30
Bisoprolol Fumarate	Bisoprolol fumarate 2.5 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-233	72888-0233-01
Bisoprolol fumarate	Bisoprolol fumarate 5 mg/1	TabletOral	Natco Pharma USA LLC	69339-236	69339-0236-0169339-0236-03
Bisoprolol fumarate	Bisoprolol fumarate 10 mg/1	TabletOral	Natco Pharma USA LLC	69339-237	69339-0237-0169339-0237-03
Bisoprolol Fumarate	Bisoprolol fumarate 5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8671	68788-8671-01
Bisoprolol Fumarate	Bisoprolol fumarate 5 mg/1	TabletOral	Harman Finochem Limited	82638-107	82638-0107-0182638-0107-02
Bisoprolol Fumarate	Bisoprolol fumarate 10 mg/1	TabletOral	Harman Finochem Limited	82638-108	82638-0108-0182638-0108-02
Bisoprolol Fumarate	Bisoprolol fumarate 10 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries Limited	70095-019	70095-0019-0170095-0019-02

All 41 Bisoprolol fumarate NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Bisoprolol fumarate	Bisoprolol fumarate 10 mg/1	TabletOral	Solco Healthcare US, LLC	43547-617