NDC 50458-920-10 - Levaquin

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
50458-920
Requested NDC
50458-920-10
Package NDCs from labels
50458-920-50, 50458-920-10
Manufacturer
Janssen Pharmaceuticals, Inc. | DAIICHI SANKYO PROPHARMA CO.,LTD. | Janssen Ortho, LLC | Eurofins Lancaster Laboratories, Inc | Alfresa Fine Chemical Corporation
Effective date
2021-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LevaquinJanssen Pharmaceuticals, Inc. | DAIICHI SANKYO PROPHARMA CO.,LTD. | Janssen Ortho, LLC | Eurofins Lancaster Laboratories, Inc | Alfresa Fine Chemical Corporation2021-01-08HUMAN PRESCRIPTION DRUG LABEL
LEVAQUINRedPharm Drug Inc. | Janssen Pharmaceutica, N.V. | Janssen Ortho, LLC | Hospira, Inc. | Ortho-McNeil-Janssen Pharmaceuticals Inc. | Lancaster Laboratories2011-07-27HUMAN PRESCRIPTION DRUG LABEL
LEVAQUIN - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-06-23HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-920-10EA - Each50458-920b3c3e262-0c30-4e70-bcd5-79359b65325812012-07-24
50458-920-50EA - Each50458-920b9f5bc91-31ed-40d4-bb35-94b465467aac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
levofloxacin anhydrousACTIVE MOIETYRIX4E89Y14LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
crospovidoneINACTIVE INGREDIENT68401960MKLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
dextroseINACTIVE INGREDIENTIY9XDZ35W2LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
ferric oxide redINACTIVE INGREDIENT1K09F3G675LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
glycerinINACTIVE INGREDIENTPDC6A3C0OXLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
hydrochloric acidINACTIVE INGREDIENTQTT17582CBLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
hypromellosesINACTIVE INGREDIENT3NXW29V3WOLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
sucroseINACTIVE INGREDIENTC151H8M554LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
waterINACTIVE INGREDIENT059QF0KO0RLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED LEVAQUIN (LEVOFLOXACIN) SOLUTION LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION [JANSSEN PHARMACEUTICALS, INC.]15
levofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
levofloxacinACTIVE MOIETY6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
levofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
levofloxacinACTIVE MOIETY6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
crospovidoneINACTIVE INGREDIENT68401960MKLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

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 1 of 111 · 2,201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LevofloxacinLEVOFLOXACINRedpharm Drug5a65b2bc-9edc-f193-e063-6394a90a01042026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199884
unii: 6GNT3Y5LMF
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
levofloxacinLEVOFLOXACINCoupler LLC59f387a4-4dfa-ba71-e063-6294a90a340c2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINMajor Pharmaceuticalsac4001ca-882f-4d9b-a570-c1b9d7fd68302026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.9f944b63-9b60-437a-ba57-d14d7976bc322026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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