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 89 of 111 · 2,208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE66a91768-6012-485a-b569-a293ea6d48802024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc43539766-2e70-4b42-b64b-1d30367b2eb92024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINAurobindo Pharma Limited529ac72c-c4a0-4001-8cf9-b94f5bf7265c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACIN IN 5% DEXTROSEEugia US LLC7d3f83bf-2db7-4657-9538-406adf321ad52024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINANI Pharmaceuticals, Inc.a894e40b-77e4-439b-b0f8-9a5cc7a1dd902024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1a8c8804-1d6b-b5a5-e063-6394a90a12602024-06-18WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINEugia US LLC4d400bf9-988f-42ec-93f1-e71a93a324b22024-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.72cb9372-e9f8-3ca1-e053-2a91aa0ad8202024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
ndc (package): 68071-4512-2
ndc (package): 68071-4512-3
ndc (package): 68071-4512-1
ndc (product): 68071-4512
ndc11 (package): 68071451201
rxcui: 199885
spl id: 1a907884-caea-cc4d-e063-6394a90acac4
spl set id: 72cb9372-e9f8-3ca1-e053-2a91aa0ad820
unii: 6GNT3Y5LMF
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
toty Solaria BodyOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDECHIPICAN LLC1a121b17-3621-6bc1-e063-6394a90ac9a12024-06-04WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
unii: 15FIX9V2JP
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.19b19023-1340-6609-e063-6394a90a6eaf2024-05-30WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Nude BeachTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee2842c3-65e0-3904-e053-2a95a90aabff2024-05-22WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 FirecrackerTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee026a1c-885b-256f-e053-2a95a90af5642024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic SPF 50 Mineral Sunscreen Vanilla CocoTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCec96dee8-85e8-3147-e053-2995a90aaf532024-05-22WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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