FDA.reportPublic FDA data

NDC 68071-4512-01 - 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
68071-4512
Requested NDC
68071-4512-01
Package NDCs from labels
68071-4512-3, 68071-4512-2, 68071-4512-1, 68071-4512-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levofloxacin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4512-1Levofloxacin1 in 1 BOTTLETABLET, FILM COATED17
68071-4512-2Levofloxacin2 in 1 BOTTLETABLET, FILM COATED27
68071-4512-3Levofloxacin3 in 1 BOTTLETABLET, FILM COATED37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4512LEVOFLOXACIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 3 package rows20240612_72cb9372-e9f8-3ca1-e053-2a91aa0ad820.zip

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 86 of 111 · 2,208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINGolden State Medical Supply, Inc.bfe280be-0789-69fa-e053-2a95a90a0e132024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINBryant Ranch Prepack171ab6c6-8eb5-4716-926f-cee52b7d09682024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199884
unii: 6GNT3Y5LMF
LEVOFLOXACINLEVOFLOXACINGland Pharma Limitedba69722b-d7f2-4519-8a63-9ee91294c4992024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
unii: 15FIX9V2JP
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
unii: 15FIX9V2JP
Freaks of Nature Peak Performance SPF50FREAKS OF NATURE PEAK PERFORMANCE SPF50Milbar Laboratories20b18cea-95e9-3527-e063-6294a90a4db42024-08-30WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINBryant Ranch Prepack54a02488-586d-4c4e-8a35-68a067bdd6e32024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 311296
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINBryant Ranch Prepackb7a614b0-f604-48e1-9919-21da8f939d932024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDermio Dermatology LLC204973ce-dba4-8235-e063-6394a90a015c2024-08-22WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINBryant Ranch Prepack804ec547-5b89-4fd0-89b3-7445543e563e2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
unii: 6GNT3Y5LMF
MACKENZIES OCEAN SAFE SUNSCREENTITANIUM DIOXIDENaturally Uncommon, LLC1fd0a790-c66c-216f-e063-6294a90ae9712024-08-16WarningsExact identifier
unii: 15FIX9V2JP
levofloxacinLEVOFLOXACINZydus Lifesciences Limitedffa121b8-388f-4d7b-af48-d4aa8d9b59612024-08-16Exact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINCamber Pharmaceuticals, Inc.b43e9b51-568c-4d84-bbd1-d237120056c42024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
ndc (product): 31722-722
rxcui: 199885
rxcui: 311296
rxcui: 199884
spl id: 1fa0a846-34d8-d6f5-e063-6394a90a8e54
spl set id: b43e9b51-568c-4d84-bbd1-d237120056c4
unii: 6GNT3Y5LMF
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb737146d-fb50-4ed6-ab5e-6aff3393992a2024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54b07420-6a30-4481-99f5-a7d6a4df898c2024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65659277-cd30-453c-929e-3651c9f19da82024-08-07WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior28ae9c39-eb79-4a19-8149-af8d8e7901ae2024-08-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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