NDC 85534-0097-01 - Levofloxacin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 85534-0097
Requested NDC: 85534-0097-01
Package NDCs from labels: 85534-0097-0, 85534-0097-1, 85534-0097-2, 85534-0097-3, 85534-0097-4, 85534-0097-5, 85534-0097-6, 85534-0097-01
Manufacturer: HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date: 2026-07-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Levofloxacin - HAWAII REPACK, INC. \| ASCLEMED USA INC. DBA ENOVACHEM	HAWAII REPACK, INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-07-18	HUMAN PRESCRIPTION DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 87 of 113 · 2,243 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
blink gel tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	6f7e06c3-204d-459a-af8f-c46be9ad0e8d	2024-09-20	Warnings	Exact identifier unii: B697894SGQ
Levofloxacin	LEVOFLOXACIN	Golden State Medical Supply, Inc.	bfe280be-0789-69fa-e053-2a95a90a0e13	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 199885 rxcui: 311296 rxcui: 199884 unii: 6GNT3Y5LMF
Calamine	CALAMINE AND ZINC OXIDE	Strategic Sourcing Services, LLC	22173332-9d09-768c-e063-6394a90a94e1	2024-09-14	Warnings	Exact identifier unii: 1K09F3G675
Leader Preservative-Free Ultra Lubricating Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Cardinal Health	2a2aa620-ca63-4698-88fd-fc263b8fa0d1	2024-09-07	Warnings	Exact identifier unii: B697894SGQ
Proceuticals Private Label by TiZO tinted mineral sunscreen stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	2179a2ff-9425-5b2c-e063-6294a90a45b6	2024-09-06	Warnings	Exact identifier unii: 15FIX9V2JP
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	171ab6c6-8eb5-4716-926f-cee52b7d0968	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 199884 unii: 6GNT3Y5LMF
LEVOFLOXACIN	LEVOFLOXACIN	Gland Pharma Limited	ba69722b-d7f2-4519-8a63-9ee91294c499	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 6GNT3Y5LMF
EltaMD UV Physical Rosy Tint SPF40	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	6bc4d2d4-ef62-4ec0-b514-17257603bac2	2024-09-05	Warnings	Exact identifier unii: 15FIX9V2JP
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	20e86260-d641-c9ac-e063-6394a90ac07d	2024-08-30	Warnings	Exact identifier unii: 15FIX9V2JP
Freaks of Nature Peak Performance SPF50	FREAKS OF NATURE PEAK PERFORMANCE SPF50	Milbar Laboratories	20b18cea-95e9-3527-e063-6294a90a4db4	2024-08-30	Warnings	Exact identifier unii: 15FIX9V2JP
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	54a02488-586d-4c4e-8a35-68a067bdd6e3	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 311296 unii: 6GNT3Y5LMF
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	b7a614b0-f604-48e1-9919-21da8f939d93	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 199885 unii: 6GNT3Y5LMF
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE AND ZINC OXIDE	Dermio Dermatology LLC	204973ce-dba4-8235-e063-6394a90a015c	2024-08-22	Warnings	Exact identifier unii: 15FIX9V2JP
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	804ec547-5b89-4fd0-89b3-7445543e563e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 199885 unii: 6GNT3Y5LMF
MACKENZIES OCEAN SAFE SUNSCREEN	TITANIUM DIOXIDE	Naturally Uncommon, LLC	1fd0a790-c66c-216f-e063-6294a90ae971	2024-08-16	Warnings	Exact identifier unii: 15FIX9V2JP
levofloxacin	LEVOFLOXACIN	Zydus Lifesciences Limited	ffa121b8-388f-4d7b-af48-d4aa8d9b5961	2024-08-16		Exact identifier rxcui: 199885 rxcui: 311296 rxcui: 199884 unii: 6GNT3Y5LMF
Levofloxacin	LEVOFLOXACIN	Camber Pharmaceuticals, Inc.	b43e9b51-568c-4d84-bbd1-d237120056c4	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 199885 rxcui: 311296 rxcui: 199884 unii: 6GNT3Y5LMF
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1f4491ab-95b0-cc14-e063-6394a90a73ca	2024-08-09	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b737146d-fb50-4ed6-ab5e-6aff3393992a	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54b07420-6a30-4481-99f5-a7d6a4df898c	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.