FDA.reportPublic FDA data

NDC 61919-992-07 - 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
61919-992
Requested NDC
61919-992-07
Package NDCs from labels
61919-992-07, 61919-992-10, 61919-992-14, 61919-992-30
Manufacturer
Direct RX
Effective date
2015-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levofloxacin - Direct RXDirect RX2015-08-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-992-302020-01-31C16284748780-19d75b9cf-f5f3-f424-e053-dadaa90a57ceLEVOFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-992-07Levofloxacin7 in 1 BOTTLETABLET, FILM COATED73
61919-992-10Levofloxacin10 in 1 BOTTLETABLET, FILM COATED103
61919-992-14Levofloxacin14 in 1 BOTTLETABLET, FILM COATED143
61919-992-30Levofloxacin30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-992LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 4 package rows20150807_6f38551b-7223-4e6d-8977-1c168dba1d06.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-992-07EA - Each61919-99208e5a431-1c14-4ce9-8198-1b2533a2c6a112014-05-02
61919-992-10EA - Each61919-99257a3618b-d756-468f-8179-11465c98d81612014-05-02
61919-992-14EA - Each61919-9926e4f7a7c-9d15-4c0e-8170-82e5ad51ba2d12014-05-02
61919-992-30EA - Each61919-99241324779-bb1a-4ee2-b61e-9a235f52ddd312014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3

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 5 of 144 · 2,868 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.2a4e97e0-0709-411b-92e8-6f7d669412e42026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.710c0c10-89a5-4954-8f74-acc187c5cf0f2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINChartwell RX, LLC5c6c117c-9d91-48f4-9aaa-ee70b99218c22026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
unii: 6GNT3Y5LMF
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.f14cf651-a213-4a4f-adb9-f628562af27c2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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