NDC codes

FDA NDC Directory
Product NDC (as listed)57237-058Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0058Add 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
57237-058-20572370058205723700582020 TABLET, FILM COATED in 1 BOTTLE (57237-058-20)Marketed from Mar 29, 2006
57237-058-60572370058605723700586060 TABLET, FILM COATED in 1 BOTTLE (57237-058-60)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, Film coated
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065308
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 57237-058_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8SPL ID d7e9c50b-74c7-4c0b-9c73-8802fa288cd8SPL set ID 66f8d37f-aebc-4435-af80-dfd7b3770088RxCUI 309097, 309098UNII Z49QDT0J8ZUPC 0357237059203
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

N457237005820 followed by a unit qualifier and the quantity

Package 57237-0058-20. 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 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 57237-058

What is NDC 57237-058?
57237-058 is the product NDC for Cefuroxime Axetil, Cefuroxime axetil 250 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, 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?
Rising Pharma Holdings, Inc., NDC labeler code 57237. 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.43063-65643063-0656-1443063-0656-20
Cefuroxime axetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-65743063-0657-2043063-0657-60

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
ProductStrengthForm · routeLabelerProduct NDC
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralNorthStar Rx LLC16714-400
Cefuroxime AxetilCefuroxime axetil 500 mg/1TabletOralNorthStar Rx LLC16714-401
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-623
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralA-S Medication Solutions50090-0781
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralA-S Medication Solutions50090-0782
Cefuroxime AxetilCefuroxime axetil 500 mg/1TabletOralA-S Medication Solutions50090-4153
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralA-S Medication Solutions50090-6999
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralA-S Medication Solutions50090-7095
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralA-S Medication Solutions50090-7667
Cefuroxime AxetilCefuroxime axetil 500 mg/1TabletOralA-S Medication Solutions50090-7668
Cefuroxime AxetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-059
Cefuroxime AxetilCefuroxime axetil 125 mg/1TabletOralAurobindo Pharma Limited65862-698
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralAurobindo Pharma Limited65862-699
Cefuroxime AxetilCefuroxime axetil 500 mg/1TabletOralAurobindo Pharma Limited65862-700
Cefuroxime AxetilCefuroxime axetil 500 mg/1TabletOralCoupler LLC67046-1081
Cefuroxime AxetilCefuroxime axetil 250 mg/1TabletOralCoupler LLC67046-1307
Cefuroxime AxetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-2079
Cefuroxime AxetilCefuroxime axetil 250 mg/1Tablet, Film coatedOralRedpharm Drug67296-2265
Cefuroxime AxetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3899
Cefuroxime AxetilCefuroxime axetil 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8905

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