NDC codes

FDA NDC Directory
Product NDC (as listed)70518-0453Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-0453Add 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
70518-0453-3705180453037051804530330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-3)Marketed from May 13, 2024

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
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076710
Marketing start
Listing expires
Identifiers
Product ID 70518-0453_5528cb6f-3e02-f6ce-e063-6294a90a7aa3SPL ID 5528cb6f-3e02-f6ce-e063-6294a90a7aa3SPL set ID f14cf651-a213-4a4f-adb9-f628562af27cRxCUI 199885UNII 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

N470518045303 followed by a unit qualifier and the quantity

Package 70518-0453-03. 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 tablet 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 Br…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-0453

What is NDC 70518-0453?
70518-0453 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. 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?
REMEDYREPACK INC., NDC labeler code 70518. 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 076710

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

FDA NDC Directory listings under ANDA 076710
ProductStrengthForm · routeLabelerProduct NDC
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6351
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6352
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6353
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-428
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-429
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-430
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-327
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-666
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-947
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Limited55111-279
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Limited55111-280
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Limited55111-281
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-5897
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-5898
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0932

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