What is NDC 16714-400?

16714-400 is the product NDC for Cefuroxime Axetil, Cefuroxime axetil 250 mg/1 tablet, listed with the FDA by NorthStar Rx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

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 Cefuroxime Axetil?

40 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cefuroxime Axetil NDC 16714-400 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0400Add 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
16714-400-01	1671404000116714040001	20 TABLET in 1 BOTTLE (16714-400-01)Marketed from Mar 29, 2006
16714-400-02	1671404000216714040002	60 TABLET in 1 BOTTLE (16714-400-02)Marketed from Mar 29, 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): Cefuroxime Axetil
Generic name (nonproprietary): cefuroxime axetil
Active ingredients: Cefuroxime axetil — 250 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NorthStar Rx LLCNDC labeler code 16714
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065308
Marketing start: Mar 29, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 16714-400_c89c84c5-710f-4a4a-8171-c38bee355c1fSPL ID c89c84c5-710f-4a4a-8171-c38bee355c1fSPL set ID fd79c41e-b0e9-47dc-a3ce-caacdc66bc96RxCUI 309097, 309098UNII Z49QDT0J8ZUPC 0316714401010, 0316714400013
Pharmacologic class: Cephalosporin Antibacterial

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

N416714040001 followed by a unit qualifier and the quantity

Package 16714-0400-01. 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 Apr 30, 2024.

Indications (excerpt from the label)

Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: ( 1 ) Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediatric patients) ( 1.2 ) Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3 ) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4 ) Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5 ) Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6 ) Uncomplicated gonorrhea (adul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-400

What is NDC 16714-400?: 16714-400 is the product NDC for Cefuroxime Axetil, Cefuroxime axetil 250 mg/1 tablet, 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?: Cefuroxime Axetil.
What is the active ingredient?: Cefuroxime axetil.
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 Cefuroxime Axetil?: 40 other product NDCs are listed under this name. See all Cefuroxime Axetil 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 Cefuroxime Axetil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0571	80425-0571-0180425-0571-02
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7542	00904-7542-10
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8905	68788-8905-02
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	Coupler LLC	67046-1307	67046-1307-03
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	TabletOral	Coupler LLC	67046-1081	67046-1081-03
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-283	60687-0283-94
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3215	70518-3215-04
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-272	60687-0272-94
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-656	43063-0656-1443063-0656-20
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-657	43063-0657-2043063-0657-60

All 41 Cefuroxime Axetil NDCs

Other NDCs under ANDA 065308

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

FDA NDC Directory listings under ANDA 065308
Product	Strength	Form · route	Labeler	Product NDC
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	TabletOral	NorthStar Rx LLC	16714-401
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-623
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	A-S Medication Solutions	50090-0781
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	A-S Medication Solutions	50090-0782
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	TabletOral	A-S Medication Solutions	50090-4153
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	A-S Medication Solutions	50090-6999
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	A-S Medication Solutions	50090-7095
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	A-S Medication Solutions	50090-7667
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	TabletOral	A-S Medication Solutions	50090-7668
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-058
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-059
Cefuroxime Axetil	Cefuroxime axetil 125 mg/1	TabletOral	Aurobindo Pharma Limited	65862-698
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	Aurobindo Pharma Limited	65862-699
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	TabletOral	Aurobindo Pharma Limited	65862-700
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	TabletOral	Coupler LLC	67046-1081
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	TabletOral	Coupler LLC	67046-1307
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2079
Cefuroxime Axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2265
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3899
Cefuroxime Axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8905

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