NDC codes

FDA NDC Directory
Product NDC (as listed)16714-529Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0529Add 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
16714-529-01167140529011671405290130 TABLET, FILM COATED in 1 BOTTLE (16714-529-01)Marketed from Dec 27, 2006
16714-529-021671405290216714052902100 TABLET, FILM COATED in 1 BOTTLE (16714-529-02)Marketed from Dec 27, 2006

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
NorthStar Rx LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077910
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 16714-529_169e7bf6-19d7-4dc5-bfc7-35c5a8e4cf18SPL ID 169e7bf6-19d7-4dc5-bfc7-35c5a8e4cf18SPL set ID 4bf3278c-116f-4db7-9af0-08faaf7691a4RxCUI 854901, 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

N416714052901 followed by a unit qualifier and the quantity

Package 16714-0529-01. 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. 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 16714-529

What is NDC 16714-529?
16714-529 is the product NDC for Bisoprolol Fumarate, Bisoprolol fumarate 5 mg/1 tablet, film coated, listed with the FDA by NorthStar Rx LLC. It has 2 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?
NorthStar Rx LLC, NDC labeler code 16714. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bisoprolol FumarateBisoprolol fumarate 5 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.64980-70964980-0709-0164980-0709-03
Bisoprolol FumarateBisoprolol fumarate 10 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.64980-71064980-0710-0164980-0710-03
Bisoprolol FumarateBisoprolol fumarate 2.5 mg/1Tablet, Film coatedOralTruPharma LLC52817-26852817-0268-30
Bisoprolol FumarateBisoprolol fumarate 2.5 mg/1Tablet, Film coatedOralAdvagen Pharma Ltd72888-23372888-0233-01
Bisoprolol fumarateBisoprolol fumarate 5 mg/1TabletOralNatco Pharma USA LLC69339-23669339-0236-0169339-0236-03
Bisoprolol fumarateBisoprolol fumarate 10 mg/1TabletOralNatco Pharma USA LLC69339-23769339-0237-0169339-0237-03
Bisoprolol FumarateBisoprolol fumarate 5 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-867168788-8671-01
Bisoprolol FumarateBisoprolol fumarate 5 mg/1TabletOralHarman Finochem Limited82638-10782638-0107-0182638-0107-02
Bisoprolol FumarateBisoprolol fumarate 10 mg/1TabletOralHarman Finochem Limited82638-10882638-0108-0182638-0108-02
Bisoprolol FumarateBisoprolol fumarate 10 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries Limited70095-01970095-0019-0170095-0019-02

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
ProductStrengthForm · routeLabelerProduct NDC
Bisoprolol FumarateBisoprolol fumarate 10 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-530
Bisoprolol FumarateBisoprolol fumarate 5 mg/1Tablet, Film coatedOralAvPAK50268-127
Bisoprolol FumarateBisoprolol fumarate 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-087

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