What is NDC 0143-9316?

0143-9316 is the product NDC for Levofloxacin, Levofloxacin 500 mg/100mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levofloxacin NDC 0143-9316 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9316Add 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 NDC	11-digit (billing)	Package	Copy
0143-9316-24	0014393162400143931624	24 BAG in 1 CARTON (0143-9316-24) / 100 mL in 1 BAG (0143-9316-01)Marketed from Sep 16, 2011

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 — 500 mg/100mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091375
Marketing start: Sep 16, 2011
Listing expires: Dec 31, 2026
Identifiers: Product ID 0143-9316_05cdb9d7-2bce-400d-8565-8a76c4a1a8e3SPL ID 05cdb9d7-2bce-400d-8565-8a76c4a1a8e3SPL set ID f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5RxCUI 1665497, 1665507, 1665515UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400143931624 followed by a unit qualifier and the quantity

Package 00143-9316-24. 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 Mar 27, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin injection is 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 injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). 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 ) a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9316

What is NDC 0143-9316?: 0143-9316 is the product NDC for Levofloxacin, Levofloxacin 500 mg/100mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1358	67046-1358-03
levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4568	70518-4568-00
levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1078	67046-1078-03
levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc	68788-8809	68788-8809-0168788-8809-0268788-8809-04+1 more
levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8772	68788-8772-0168788-8772-0268788-8772-03+2 more
Levofloxacinllevofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0388	80425-0388-0180425-0388-02
Levofloxacin	Levofloxacin 250 mg/50mL	Injection, SolutionIntravenous	Hospira, Inc	0409-2220	00409-2220-24
Levofloxacin	Levofloxacin 500 mg/100mL	Injection, SolutionIntravenous	Hospira, Inc	0409-3330	00409-3330-24
Levofloxacin	Levofloxacin 750 mg/150mL	Injection, SolutionIntravenous	Hospira, Inc	0409-4444	00409-4444-24
Levofloxacin	Levofloxacin 25 mg/mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-852	70954-0852-1070954-0852-2070954-0852-30

All 121 Levofloxacin NDCs

Other NDCs under ANDA 091375

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

FDA NDC Directory listings under ANDA 091375
Product	Strength	Form · route	Labeler	Product NDC
Levofloxacin	Levofloxacin 250 mg/50mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9315
Levofloxacin	Levofloxacin 750 mg/150mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9317
Levofloxacin	Levofloxacin 750 mg/150mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9720
Levofloxacin	Levofloxacin 500 mg/100mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9721
Levofloxacin	Levofloxacin 250 mg/50mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9722