What is NDC 85534-0097?

85534-0097 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by HAWAII REPACK, INC.. It has 7 package NDCs, shown above in 10- and 11-digit form.

HAWAII REPACK, INC., NDC labeler code 85534. 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 85534-0097 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85534-0097Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85534-0097Add 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
85534-0097-0	8553400970085534009700	5 TABLET, FILM COATED in 1 BOTTLE (85534-0097-0)Marketed from Jul 18, 2026
85534-0097-1	8553400970185534009701	7 TABLET, FILM COATED in 1 BOTTLE (85534-0097-1)Marketed from Jul 18, 2026
85534-0097-2	8553400970285534009702	10 TABLET, FILM COATED in 1 BOTTLE (85534-0097-2)Marketed from Jul 18, 2026
85534-0097-3	8553400970385534009703	14 TABLET, FILM COATED in 1 BOTTLE (85534-0097-3)Marketed from Jul 18, 2026
85534-0097-4	8553400970485534009704	20 TABLET, FILM COATED in 1 BOTTLE (85534-0097-4)Marketed from Jul 18, 2026
85534-0097-5	8553400970585534009705	30 TABLET, FILM COATED in 1 BOTTLE (85534-0097-5)Marketed from Jul 18, 2026
85534-0097-6	8553400970685534009706	50 TABLET, FILM COATED in 1 BOTTLE (85534-0097-6)Marketed from Jul 18, 2026

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: HAWAII REPACK, INC.NDC labeler code 85534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201043
Marketing start: Jun 20, 2011
Listing expires: Dec 31, 2027
Identifiers: Product ID 85534-0097_56dcea85-a971-8dd4-e063-6294a90adab4SPL ID 56dcea85-a971-8dd4-e063-6294a90adab4SPL set ID 857f256c-88ac-4f73-9815-c2724edf2f1eRxCUI 199884, 199885, 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

N485534009700 followed by a unit qualifier and the quantity

Package 85534-0097-00. 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 Jul 18, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin tablets are 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 Bronchit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85534-0097

What is NDC 85534-0097?: 85534-0097 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by HAWAII REPACK, INC.. It has 7 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?: HAWAII REPACK, INC., NDC labeler code 85534. 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 201043

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

FDA NDC Directory listings under ANDA 201043
Product	Strength	Form · route	Labeler	Product NDC
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-457
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3712
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-459
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	HAWAII REPACK, INC.	85534-0098
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	HAWAII REPACK, INC.	85534-0096
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1226
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1228
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0008
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-058
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-538
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-536
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-537
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-817
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-815
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-816
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1104
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-367
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-085