What is NDC 71335-0434?

71335-0434 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-0434 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0434Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0434Add 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
71335-0434-0	7133504340071335043400	90 TABLET, FILM COATED in 1 BOTTLE (71335-0434-0)Marketed from Apr 3, 2024
71335-0434-1	7133504340171335043401	30 TABLET, FILM COATED in 1 BOTTLE (71335-0434-1)Marketed from May 7, 2018
71335-0434-2	7133504340271335043402	10 TABLET, FILM COATED in 1 BOTTLE (71335-0434-2)Marketed from Apr 19, 2018
71335-0434-3	7133504340371335043403	7 TABLET, FILM COATED in 1 BOTTLE (71335-0434-3)Marketed from Sep 5, 2018
71335-0434-4	7133504340471335043404	14 TABLET, FILM COATED in 1 BOTTLE (71335-0434-4)Marketed from Mar 5, 2018
71335-0434-5	7133504340571335043405	5 TABLET, FILM COATED in 1 BOTTLE (71335-0434-5)Marketed from Mar 30, 2018
71335-0434-6	7133504340671335043406	20 TABLET, FILM COATED in 1 BOTTLE (71335-0434-6)Marketed from Feb 13, 2018
71335-0434-7	7133504340771335043407	60 TABLET, FILM COATED in 1 BOTTLE (71335-0434-7)Marketed from Feb 14, 2018
71335-0434-8	7133504340871335043408	3 TABLET, FILM COATED in 1 BOTTLE (71335-0434-8)Marketed from Mar 10, 2022
71335-0434-9	7133504340971335043409	50 TABLET, FILM COATED in 1 BOTTLE (71335-0434-9)Marketed from Apr 21, 2021

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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
Marketing start: Jan 9, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 71335-0434_fb951968-65db-479b-b313-2ac274ea0df2SPL ID fb951968-65db-479b-b313-2ac274ea0df2SPL set ID 804ec547-5b89-4fd0-89b3-7445543e563eRxCUI 199885UNII 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

N471335043400 followed by a unit qualifier and the quantity

Package 71335-0434-00. 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 Aug 20, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin is 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0434

What is NDC 71335-0434?: 71335-0434 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 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	REMEDYREPACK INC.	70518-0587
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3245
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3311
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	50090-3314
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0794
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	VERITYRX, LLC	83939-0020
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4512
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0719
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	DirectRx	72189-338
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3093
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3218
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0968
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-002
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-769
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-248
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4738
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	ADVANCED RX PHARMACY OF TENNESSEE, LLC	80425-0007
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	DIRECT RX	61919-426
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-721

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