FDA.reportPublic FDA data

NDC 50383-286-10 - 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
50383-286
Requested NDC
50383-286-10
Package NDCs from labels
50383-286-16, 50383-286-08, 50383-286-04, 50383-286-10, 50383-286-11, 50383-286-20, 50383-286-21
Manufacturer
Akorn | Akorn Operating Company LLC
Effective date
2022-11-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levofloxacin - Akorn | Akorn Operating Company LLCAkorn | Akorn Operating Company LLC2022-11-01HUMAN PRESCRIPTION DRUG LABEL
Levofloxacin - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2018-11-30HUMAN PRESCRIPTION DRUG LABEL
Levofloxacin - Department of State Health Services, Pharmacy BranchDepartment of State Health Services, Pharmacy Branch2016-03-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
50383-286-04These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996
50383-286-08These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996
50383-286-11These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996
50383-286-16These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996
50383-286-21These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-286-04Levofloxacin1 in 1 CARTONSOLUTION127
50383-286-04Levofloxacin100 mL in 1 BOTTLESOLUTION10027
50383-286-08Levofloxacin200 mL in 1 BOTTLESOLUTION20027
50383-286-08Levofloxacin1 in 1 CARTONSOLUTION127
50383-286-10Levofloxacin10 mL in 1 CUP, UNIT-DOSESOLUTION1027
50383-286-11Levofloxacin4 in 1 CASESOLUTION427
50383-286-11Levofloxacin10 in 1 TRAYSOLUTION1027
50383-286-16Levofloxacin480 mL in 1 BOTTLESOLUTION48027
50383-286-16Levofloxacin1 in 1 CARTONSOLUTION127
50383-286-20Levofloxacin20 mL in 1 CUP, UNIT-DOSESOLUTION2027
50383-286-21Levofloxacin10 in 1 TRAYSOLUTION1027
50383-286-21Levofloxacin4 in 1 CASESOLUTION427

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-286LEVOFLOXACIN SOLUTION [AKORN]27Legacy NDC, 12 package rows20221103_c6c7322b-6a89-4d23-90d1-bf9327bd6d91.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-286-04ML - Milliliter50383-28663fccffd-ce22-4944-8ebe-0bb4d09c834812012-07-24
50383-286-08ML - Milliliter50383-286d78afd86-ca6e-49d3-af41-249b2227697912012-07-24
50383-286-10ML - Milliliter50383-2861899d499-bb8d-4076-9d90-bbbb443a007412014-02-04
50383-286-11ML - Milliliter50383-2868f6badf6-2c01-4a69-ba09-c02f60ea5cf712014-02-04
50383-286-16ML - Milliliter50383-286e9f4bf6b-7253-4fd0-97b5-acc7159f25ca12012-07-24
50383-286-20ML - Milliliter50383-2863c30225d-af52-4e5f-8178-287397dee65c12014-02-04
50383-286-21ML - Milliliter50383-2862767b0db-d598-479b-ba98-d754ad52721a12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RLEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
GRAPEINACTIVE INGREDIENT6X543N684KLEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
SUCROSEINACTIVE INGREDIENTC151H8M554LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RLEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]11

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 46 · 906 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
LevofloxacinLEVOFLOXACINRedpharm Drug5a65b2bc-9edc-f193-e063-6394a90a01042026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINCoupler LLC59f387a4-4dfa-ba71-e063-6294a90a340c2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: PQ6CK8PD0R
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LevofloxacinLEVOFLOXACINMajor Pharmaceuticalsac4001ca-882f-4d9b-a570-c1b9d7fd68302026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.9f944b63-9b60-437a-ba57-d14d7976bc322026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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