What is NDC 72189-338?

72189-338 is the product NDC for Levofloxacin, Levofloxacin 750 mg/1 tablet, film coated, listed with the FDA by DirectRx. It has 4 package NDCs, shown above in 10- and 11-digit form.

DirectRx, NDC labeler code 72189. 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?

123 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 72189-338 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-338Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0338Add 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
72189-338-05	7218903380572189033805	5 TABLET, FILM COATED in 1 BOTTLE (72189-338-05)Marketed from Mar 21, 2022
72189-338-07	7218903380772189033807	7 TABLET, FILM COATED in 1 BOTTLE (72189-338-07)Marketed from Mar 21, 2022
72189-338-10	7218903381072189033810	10 TABLET, FILM COATED in 1 BOTTLE (72189-338-10)Marketed from Mar 21, 2022
72189-338-14	7218903381472189033814	14 TABLET, FILM COATED in 1 BOTTLE (72189-338-14)Marketed from Mar 21, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 750 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: DirectRxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
Marketing start: Mar 21, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-338_2c3d9c0f-6e78-fa93-e063-6394a90a6dbbSPL ID 2c3d9c0f-6e78-fa93-e063-6394a90a6dbbSPL set ID dabedb15-5b55-3853-e053-2995a90aa44eRxCUI 311296UNII 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

N472189033805 followed by a unit qualifier and the quantity

Package 72189-0338-05. 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 Jan 21, 2025.

Indications (excerpt from the label)

1.1 Nosocomial Pneumonia Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli,Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pn…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-338

What is NDC 72189-338?: 72189-338 is the product NDC for Levofloxacin, Levofloxacin 750 mg/1 tablet, film coated, listed with the FDA by DirectRx. It has 4 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?: DirectRx, NDC labeler code 72189. 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?: 123 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 750 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-769	60760-0769-10
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 750 mg/150mL	Injection, SolutionIntravenous	Hospira, Inc	0409-4444	00409-4444-24
Levofloxacin	Levofloxacin 500 mg/100mL	Injection, SolutionIntravenous	Hospira, Inc	0409-3330	00409-3330-24

All 124 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
Product	Strength	Form · route	Labeler	Product NDC
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	ADVANCED RX PHARMACY OF TENNESSEE, LLC	80425-0007
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-8340
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-833
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0593
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0077
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3214
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3245
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0794
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-1860
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3311
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3314
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0587
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-6938
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3511
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2074
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0719
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4512
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3093
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	VERITYRX, LLC	83939-0020
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-002

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