NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3311Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3311Add 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
50090-3311-050090331100500903311007 TABLET, FILM COATED in 1 BOTTLE (50090-3311-0)Marketed from Feb 1, 2018
50090-3311-1500903311015009033110110 TABLET, FILM COATED in 1 BOTTLE (50090-3311-1)Marketed from Dec 22, 2017
50090-3311-4500903311045009033110414 TABLET, FILM COATED in 1 BOTTLE (50090-3311-4)Marketed from Feb 5, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Levofloxacin
Generic name (nonproprietary)
levofloxacin
Active ingredients
Levofloxacin — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
Marketing start
Listing expires
Identifiers
Product ID 50090-3311_f0b328c3-8092-456e-a360-43166366b1baSPL ID f0b328c3-8092-456e-a360-43166366b1baSPL set ID 1538ec66-f385-401e-8cfb-d794691e7176RxCUI 199884, 199885, 311296UNII 6GNT3Y5LMF

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

N450090331100 followed by a unit qualifier and the quantity

Package 50090-3311-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). • Pneumonia: Nosocomial ( 1.1 ) and Community Acquired ( 1.2 , 1.3 ) • Skin and Skin Structure Infections (SSSI): Complicated ( 1.4 ) and Uncomplicated ( 1.5 ) • Chronic bacterial prostatitis ( 1.6 ) • Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7 ) • Plague in adult and pediatric patients ( 1.8 ) • Urinary Tract Infections (UTI): Complicated ( 1.9 , 1.10 ) and Uncomplicated ( 1.12 ) • Acute Pyelonephritis ( 1.11 ) • Acute Bacterial Exacerbation of Chronic …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-3311

What is NDC 50090-3311?
50090-3311 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Levofloxacin.
What is the active ingredient?
Levofloxacin.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levofloxacin?
123 other product NDCs are listed under this name. See all Levofloxacin 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 Levofloxacin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralCoupler LLC67046-135867046-1358-03
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-456870518-4568-00
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-76960760-0769-10
levofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralCoupler LLC67046-107867046-1078-03
levofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc68788-880968788-8809-0168788-8809-0268788-8809-04+1 more
levofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-877268788-8772-0168788-8772-0268788-8772-03+2 more
LevofloxacinllevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-038880425-0388-0180425-0388-02
LevofloxacinLevofloxacin 250 mg/50mLInjection, SolutionIntravenousHospira, Inc0409-222000409-2220-24
LevofloxacinLevofloxacin 750 mg/150mLInjection, SolutionIntravenousHospira, Inc0409-444400409-4444-24
LevofloxacinLevofloxacin 500 mg/100mLInjection, SolutionIntravenousHospira, Inc0409-333000409-3330-24

All 124 Levofloxacin NDCs

Other NDCs under ANDA 202801

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

FDA NDC Directory listings under ANDA 202801
ProductStrengthForm · routeLabelerProduct NDC
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralADVANCED RX PHARMACY OF TENNESSEE, LLC80425-0007
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-8340
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralProficient Rx LP63187-833
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0593
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0077
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3214
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3245
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0794
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-1860
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3314
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0587
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-6938
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3511
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2074
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralDirectRx72189-338
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0719
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4512
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3093
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralVERITYRX, LLC83939-0020
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-002

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