NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3218Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3218Add 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
68071-3218-1680713218016807132180110 TABLET, FILM COATED in 1 BOTTLE (68071-3218-1)Marketed from Jan 18, 2018
68071-3218-368071321803680713218033 TABLET, FILM COATED in 1 BOTTLE (68071-3218-3)Marketed from Jan 18, 2018
68071-3218-968071321809680713218099 TABLET, FILM COATED in 1 BOTTLE (68071-3218-9)Marketed from Jan 18, 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 — 750 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
Marketing start
Listing expires
Identifiers
Product ID 68071-3218_1cc0e391-4f43-e2e8-e063-6394a90a3c46SPL ID 1cc0e391-4f43-e2e8-e063-6394a90a3c46SPL set ID 631523e7-7d67-0cc3-e053-2a91aa0abb62RxCUI 311296UNII 6GNT3Y5LMFUPC 0368071321814

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

N468071321801 followed by a unit qualifier and the quantity

Package 68071-3218-01. 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 indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria ( 1 , 12.4 ). • Pneumonia: Nosocomial ( 1.1 ) and Community Acquired ( 1.2 , 1.3 ) • Skin and Skin Structure Infections: Complicated ( 1.4 ) and Uncomplicated ( 1.5 ) • Chronic bacterial prostatitis ( 1.6 ) • Inhalational Anthrax, Post-Exposure ( 1.7 ) • Plague ( 1.8 ) • Urinary Tract Infections: Complicated ( 1.9 , 1.10 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-3218

What is NDC 68071-3218?
68071-3218 is the product NDC for Levofloxacin, Levofloxacin 750 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. 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?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 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 coatedOralREMEDYREPACK INC.70518-0587
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3245
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3311
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-1860
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3314
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0794
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralVERITYRX, LLC83939-0020
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4512
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0719
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralDirectRx72189-338
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3093
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0968
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-002
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-769
LevofloxacinLevofloxacin 750 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-248
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4738
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralADVANCED RX PHARMACY OF TENNESSEE, LLC80425-0007
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralDIRECT RX61919-426
LevofloxacinLevofloxacin 250 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-721
LevofloxacinLevofloxacin 500 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-722

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