NDC codes

FDA NDC Directory
Product NDC (as listed)67296-1104Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-1104Add 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
67296-1104-567296110405672961104055 TABLET, FILM COATED in 1 BOTTLE (67296-1104-5)Marketed from Jun 20, 2011

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 — 250 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Redpharm DrugNDC labeler code 67296
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201043
Marketing start
Listing expires
Identifiers
Product ID 67296-1104_5a65b2c4-0961-618e-e063-6294a90aefaaSPL ID 5a65b2c4-0961-618e-e063-6294a90aefaaSPL set ID 5a65b2bc-9edc-f193-e063-6394a90a0104RxCUI 199884UNII 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

N467296110405 followed by a unit qualifier and the quantity

Package 67296-1104-05. 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 tablets are 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 Bronchit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67296-1104

What is NDC 67296-1104?
67296-1104 is the product NDC for Levofloxacin, Levofloxacin 250 mg/1 tablet, film coated, listed with the FDA by Redpharm Drug. It has 1 package NDC, 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?
Redpharm Drug, NDC labeler code 67296. 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?
120 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 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 500 mg/100mLInjection, SolutionIntravenousHospira, Inc0409-333000409-3330-24
LevofloxacinLevofloxacin 750 mg/150mLInjection, SolutionIntravenousHospira, Inc0409-444400409-4444-24
LevofloxacinLevofloxacin 25 mg/mLSolutionOralANI Pharmaceuticals, Inc.70954-85270954-0852-1070954-0852-2070954-0852-30

All 121 Levofloxacin NDCs

Other NDCs under ANDA 201043

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

FDA NDC Directory listings under ANDA 201043
ProductStrengthForm · routeLabelerProduct NDC
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-457
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3712
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-459
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralHAWAII REPACK, INC.85534-0098
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralHAWAII REPACK, INC.85534-0096
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralHAWAII REPACK, INC.85534-0097
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1226
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1228
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0008
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralProficient Rx LP71205-058
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-538
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-536
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-537
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-817
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-815
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-816
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-367
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-085

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