What is NDC 72789-035?

72789-035 is the product NDC for Cefuroxime axetil, Cefuroxime axetil 500 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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 72789-035 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72789-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72789-0035Add 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
72789-035-14	7278900351472789003514	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-14)Marketed from May 15, 2023
72789-035-20	7278900352072789003520	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-20)Marketed from Dec 18, 2019
72789-035-60	7278900356072789003560	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-60)Marketed from Dec 18, 2019

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 — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065496
Marketing start: Dec 1, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 72789-035_303d9134-594c-63c6-e063-6394a90a4edfSPL ID 303d9134-594c-63c6-e063-6394a90a4edfSPL set ID 15cabe73-f39d-4798-a840-115fe94f8f96RxCUI 309098UNII Z49QDT0J8ZUPC 0372789035147
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

N472789003514 followed by a unit qualifier and the quantity

Package 72789-0035-14. 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 Mar 13, 2025.

Indications (excerpt from the label)

Cefuroxime axetil tablet is 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 (adults a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72789-035

What is NDC 72789-035?: 72789-035 is the product NDC for Cefuroxime axetil, Cefuroxime axetil 500 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 3 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?: PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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 065496

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

FDA NDC Directory listings under ANDA 065496
Product	Strength	Form · route	Labeler	Product NDC
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3975
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-333
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-272
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-334
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-283
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0571
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4947
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-1637
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-216
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7542
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-215
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-991
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2159
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2157
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2158
Cefuroxime axetil	Cefuroxime axetil 500 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2168
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-656
Cefuroxime axetil	Cefuroxime axetil 250 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-657