FDA.reportPublic FDA data

NDC 0121-0872-10 - 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
0121-0872
Requested NDC
0121-0872-10
Package NDCs from labels
0121-0872-10, 0121-0872-40, 0121-0872-20
Manufacturer
Pharmaceutical Associates, Inc. | Lannett Company, Inc.
Effective date
2020-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levofloxacin - Pharmaceutical Associates, Inc. | Lannett Company, Inc.Pharmaceutical Associates, Inc. | Lannett Company, Inc.2020-04-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-0872-202024-05-06C16284748780-1d6a99b39-bc53-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use LEVOFLOXACIN ORAL SOLUTION safely and effectively. See full prescribing information for LEVOFLOXACIN ORAL SOLUTION. LEVOFLOXACIN oral solution, for oral use Initial U.S. Approval: 1996
0121-0872-202022-01-28C16284748780-1d6a99b39-bc53-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use LEVOFLOXACIN ORAL SOLUTION safely and effectively. See full prescribing information for LEVOFLOXACIN ORAL SOLUTION. LEVOFLOXACIN oral solution, for oral use Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0872-10ML - Milliliter0121-0872026e9f7b-cf5b-45ab-a818-46115b95011012020-06-05
0121-0872-20ML - Milliliter0121-08728255e754-3c9e-43bd-8074-0c5d2002aeeb12020-06-05

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 39 · 764 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
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
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
MENTOL CHINO FORTEMETHYL SALICYLATE, MENTHOL, CAMPHORLABORATORIOS H.G. C.A.12652c98-e2a8-21fc-e063-6394a90a94cb2026-08-17WarningsExact identifier
unii: 8SKN0B0MIM
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
levofloxacinLEVOFLOXACINBryant Ranch Prepackb9dc8bf3-97d9-4d1c-9a68-3ae553acdada2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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