FDA.reportPublic FDA data

Levofloxacin

Product NDC
31722-722
11-digit product format
317220722
Labeler code
31722
Product ID
31722-722_1fa0a846-34d8-d6f5-e063-6394a90a8e54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA202801
Marketing category
ANDA
Marketing start
2015-01-09
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884, 199885, 311296

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
31722-722-31Levofloxacin10 in 1 BLISTER PACKTABLET, FILM COATED109
31722-722-32Levofloxacin100 in 1 BLISTER PACKTABLET, FILM COATED1009
31722-722-50Levofloxacin50 in 1 BOTTLETABLET, FILM COATED509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-722-50EA - Each31722-7224154679b-6e00-4df8-a834-d20d1cdeda0d12016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-722LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 3 package rows20240815_b43e9b51-568c-4d84-bbd1-d237120056c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN804ec547-5b89-4fd0-89b3-7445543e563e104
199885levofloxacin 500 MG Oral TabletSCD804ec547-5b89-4fd0-89b3-7445543e563e104
199884levoFLOXacin 250 MG Oral TabletPSN1538ec66-f385-401e-8cfb-d794691e717627
199885levoFLOXacin 500 MG Oral TabletPSN1538ec66-f385-401e-8cfb-d794691e717627
311296levoFLOXacin 750 MG Oral TabletPSN1538ec66-f385-401e-8cfb-d794691e717627
199884levofloxacin 250 MG Oral TabletSCD1538ec66-f385-401e-8cfb-d794691e717627
199885levofloxacin 500 MG Oral TabletSCD1538ec66-f385-401e-8cfb-d794691e717627
311296levofloxacin 750 MG Oral TabletSCD1538ec66-f385-401e-8cfb-d794691e717627
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY1538ec66-f385-401e-8cfb-d794691e717627
199885levoFLOXacin 500 MG Oral TabletPSN16d51c1c-4144-4be7-9356-98fcee621ecd21
199885levofloxacin 500 MG Oral TabletSCD16d51c1c-4144-4be7-9356-98fcee621ecd21
199885levoFLOXacin 500 MG Oral TabletPSNbcad1dad-53aa-43dd-90f3-cc17cc9598d513
199885levofloxacin 500 MG Oral TabletSCDbcad1dad-53aa-43dd-90f3-cc17cc9598d513
199885levoFLOXacin 500 MG Oral TabletPSNbdc8b2cc-a914-4613-ac7c-e8dfe91dea1310
199885levofloxacin 500 MG Oral TabletSCDbdc8b2cc-a914-4613-ac7c-e8dfe91dea1310
199884levoFLOXacin 250 MG Oral TabletPSNb43e9b51-568c-4d84-bbd1-d237120056c49
199885levoFLOXacin 500 MG Oral TabletPSNb43e9b51-568c-4d84-bbd1-d237120056c49
199885levoFLOXacin 500 MG Oral TabletPSNaf4b7333-4f77-4ec9-e053-2a95a90a16d29
199885levoFLOXacin 500 MG Oral TabletPSN4f40d5fa-ebcc-516c-e054-00144ff8d46c9
311296levoFLOXacin 750 MG Oral TabletPSNb43e9b51-568c-4d84-bbd1-d237120056c49
311296levoFLOXacin 750 MG Oral TabletPSN4f40d5fa-ebcc-516c-e054-00144ff8d46c9
199884levofloxacin 250 MG Oral TabletSCDb43e9b51-568c-4d84-bbd1-d237120056c49
199885levofloxacin 500 MG Oral TabletSCDb43e9b51-568c-4d84-bbd1-d237120056c49
199885levofloxacin 500 MG Oral TabletSCD4f40d5fa-ebcc-516c-e054-00144ff8d46c9
199885levofloxacin 500 MG Oral TabletSCDaf4b7333-4f77-4ec9-e053-2a95a90a16d29
311296levofloxacin 750 MG Oral TabletSCD4f40d5fa-ebcc-516c-e054-00144ff8d46c9
311296levofloxacin 750 MG Oral TabletSCDb43e9b51-568c-4d84-bbd1-d237120056c49
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYb43e9b51-568c-4d84-bbd1-d237120056c49
199885levoFLOXacin 500 MG Oral TabletPSN64141d0d-0347-470f-a427-9925a2eb357e7
199885levoFLOXacin 500 MG Oral TabletPSN72cb9372-e9f8-3ca1-e053-2a91aa0ad8207
199885levofloxacin 500 MG Oral TabletSCD72cb9372-e9f8-3ca1-e053-2a91aa0ad8207
199885levofloxacin 500 MG Oral TabletSCD64141d0d-0347-470f-a427-9925a2eb357e7
199885levoFLOXacin 500 MG Oral TabletPSN80501b71-2f08-2ef5-e053-2991aa0a6e866
199885levoFLOXacin 500 MG Oral TabletPSN50732645-aa07-3bef-e054-00144ff8d46c6
199885levofloxacin 500 MG Oral TabletSCD80501b71-2f08-2ef5-e053-2991aa0a6e866
199885levofloxacin 500 MG Oral TabletSCD50732645-aa07-3bef-e054-00144ff8d46c6
199885levoFLOXacin 500 MG Oral TabletPSNdaa51cd2-b877-488a-b4a1-3b06487627c65
199885levofloxacin 500 MG Oral TabletSCDdaa51cd2-b877-488a-b4a1-3b06487627c65
199885levoFLOXacin 500 MG Oral TabletPSN05d179f5-b200-8597-e063-6394a90a10cc2
199885levofloxacin 500 MG Oral TabletSCD05d179f5-b200-8597-e063-6394a90a10cc2
199885levoFLOXacin 500 MG Oral TabletPSN427a2077-5dbb-3c5e-e063-6294a90a08391
199885levofloxacin 500 MG Oral TabletSCD427a2077-5dbb-3c5e-e063-6294a90a08391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-722-313172207223110 TABLET, FILM COATED in 1 BLISTER PACK (31722-722-31) 2015-01-090000-00-00NoNoCurrent
31722-722-3231722072232100 TABLET, FILM COATED in 1 BLISTER PACK (31722-722-32) 2015-01-090000-00-00NoNoCurrent
31722-722-503172207225050 TABLET, FILM COATED in 1 BOTTLE (31722-722-50) 2015-01-090000-00-00NoNoCurrent