FDA.reportPublic FDA data

Levofloxacin

Product NDC
43063-457
11-digit product format
430630457
Labeler code
43063
Product ID
43063-457_4d52a1c6-bbc1-0b02-e063-6294a90afa45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201043
Marketing category
ANDA
Marketing start
2011-06-20
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199885

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-457-03Levofloxacin3 in 1 BOTTLE, PLASTICTABLET, FILM COATED331
43063-457-05Levofloxacin5 in 1 BOTTLE, PLASTICTABLET, FILM COATED531
43063-457-07Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED731
43063-457-10Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1031
43063-457-14Levofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1431
43063-457-20Levofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-457-05EA - Each43063-457009e321f-7883-418e-9e0c-7178ab29a8b512013-08-02
43063-457-07EA - Each43063-45744a9cf6a-71ec-464a-a65e-d26ccc34efff12013-08-02
43063-457-10EA - Each43063-457c6ca3e40-0606-420e-9c08-bdf1dda8ef6312013-08-02
43063-457-14EA - Each43063-4573c6c06ca-9fd3-48fe-b65e-0608f016a82912021-05-05
43063-457-20EA - Each43063-457356210a4-89ce-4dcf-8f36-21919b22c49212023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-457LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]30Current NDC, Legacy NDC, 6 package rows20250121_a5ae33ad-4703-4cb2-8618-6439c906be99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSNa5ae33ad-4703-4cb2-8618-6439c906be9931
199885levofloxacin 500 MG Oral TabletSCDa5ae33ad-4703-4cb2-8618-6439c906be9931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-457-02430630457022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-02) 2012-09-250000-00-00NoNoCurrent
43063-457-03430630457033 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-03) 2012-09-250000-00-00NoNoCurrent
43063-457-05430630457055 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-05) 2012-09-250000-00-00NoNoCurrent
43063-457-07430630457077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-07) 2012-09-250000-00-00NoNoCurrent
43063-457-104306304571010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-10) 2012-09-250000-00-00NoNoCurrent
43063-457-144306304571414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-14) 2021-04-010000-00-00NoNoCurrent
43063-457-204306304572020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-20) 2022-11-020000-00-00NoNoCurrent