What is NDC 50268-127?

50268-127 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 5 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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 50268-127 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0127Add 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	Copy
50268-127-15	5026801271550268012715	50 BLISTER PACK in 1 BOX (50268-127-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-127-11)Marketed from Jan 10, 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, Film coated
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077910
Marketing start: Jan 10, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 50268-127_0e85a1ff-1540-187e-e063-6394a90a3b1eSPL ID 0e85a1ff-1540-187e-e063-6394a90a3b1eSPL set ID d540ef44-9016-9d66-e053-2a95a90a16a9RxCUI 854905UNII UR59KN573L
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

N450268012715 followed by a unit qualifier and the quantity

Package 50268-0127-15. 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 Jan 9, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Bisoprolol fumarate tablets are indicated in the management of hypertension. They 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 50268-127

What is NDC 50268-127?: 50268-127 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 5 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, 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?: AvPAK, NDC labeler code 50268. 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 077910

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

FDA NDC Directory listings under ANDA 077910
Product	Strength	Form · route	Labeler	Product NDC
Bisoprolol Fumarate	Bisoprolol fumarate 5 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-529
Bisoprolol Fumarate	Bisoprolol fumarate 10 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-530
Bisoprolol Fumarate	Bisoprolol fumarate 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-087