NDC codes

FDA NDC Directory
Product NDC (as listed)0527-1948Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00527-1948Add 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
0527-1948-6600527194866005271948661 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) / 100 mL in 1 BOTTLE, PLASTICMarketed from May 25, 2018
0527-1948-6800527194868005271948681 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) / 200 mL in 1 BOTTLE, PLASTICMarketed from May 25, 2018
0527-1948-7000527194870005271948701 BOTTLE, PLASTIC in 1 CARTON (0527-1948-70) / 480 mL in 1 BOTTLE, PLASTICMarketed from May 25, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Levofloxacin
Generic name (nonproprietary)
levofloxacin
Active ingredients
Levofloxacin — 25 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Lannett Company, LLCNDC labeler code 0527
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205222
Marketing start
Listing expires
Identifiers
Product ID 0527-1948_1bf4cfc7-7dd6-46e8-a1f2-0516ac5c363aSPL ID 1bf4cfc7-7dd6-46e8-a1f2-0516ac5c363a

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

N400527194866 followed by a unit qualifier and the quantity

Package 00527-1948-66. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0527-1948

What is NDC 0527-1948?
0527-1948 is the product NDC for Levofloxacin, Levofloxacin 25 mg/mL solution, listed with the FDA by Lannett Company, LLC. 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?
Lannett Company, LLC, NDC labeler code 0527. 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

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