NDC codes

FDA NDC Directory
Product NDC (as listed)43063-656Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0656Add 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
43063-656-14430630656144306306561414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-14)Marketed from Jul 8, 2024
43063-656-20430630656204306306562020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-20)Marketed from Feb 5, 2016

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, Film coated
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065496
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 43063-656_4139ec87-a6f3-686f-e063-6294a90aaff2SPL ID 4139ec87-a6f3-686f-e063-6294a90aaff2SPL set ID 2af8f061-c0e1-3a1c-e054-00144ff8d46cRxCUI 309097UNII Z49QDT0J8ZUPC 0343063656204
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

N443063065614 followed by a unit qualifier and the quantity

Package 43063-0656-14. 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 .

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 43063-656

What is NDC 43063-656?
43063-656 is the product NDC for Cefuroxime axetil, Cefuroxime axetil 250 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-057180425-0571-0180425-0571-02
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-754200904-7542-10
Cefuroxime AxetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-890568788-8905-02
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralCoupler LLC67046-130767046-1307-03
Cefuroxime AxetilCefuroxime axetil 500 mg/1TabletOralCoupler LLC67046-108167046-1081-03
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-28360687-0283-94
Cefuroxime AxetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-321570518-3215-04
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-27260687-0272-94
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-65743063-0657-2043063-0657-60
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-215750090-2157-00

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
ProductStrengthForm · routeLabelerProduct NDC
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3975
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-333
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-272
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-334
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-283
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-035
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0571
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4947
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-1637
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-216
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7542
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-215
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralProficient Rx LP63187-991
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2159
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2157
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2158
Cefuroxime axetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-2168
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-657

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