FDA.reportPublic FDA data

Levofloxacin

Product NDC
31722-723
11-digit product format
317220723
Labeler code
31722
Product ID
31722-723_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
750 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
LEVOFLOXACIN750 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
31722-723-20Levofloxacin20 in 1 BOTTLETABLET, FILM COATED209
31722-723-31Levofloxacin10 in 1 BLISTER PACKTABLET, FILM COATED109
31722-723-32Levofloxacin100 in 1 BLISTER PACKTABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-723-20EA - Each31722-7236e83740c-77df-484a-9c63-20e319f5346e12017-03-06

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
31722-723LEVOFLOXACIN (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
311296levoFLOXacin 750 MG Oral TabletPSN54a02488-586d-4c4e-8a35-68a067bdd6e3103
311296levofloxacin 750 MG Oral TabletSCD54a02488-586d-4c4e-8a35-68a067bdd6e3103
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
311296levoFLOXacin 750 MG Oral TabletPSN2a4e97e0-0709-411b-92e8-6f7d669412e418
311296levofloxacin 750 MG Oral TabletSCD2a4e97e0-0709-411b-92e8-6f7d669412e418
311296levoFLOXacin 750 MG Oral TabletPSNd98cf024-51fa-45a1-b247-da55aba88ca014
311296levofloxacin 750 MG Oral TabletSCDd98cf024-51fa-45a1-b247-da55aba88ca014
199884levoFLOXacin 250 MG Oral TabletPSNb43e9b51-568c-4d84-bbd1-d237120056c49
199885levoFLOXacin 500 MG Oral TabletPSNb43e9b51-568c-4d84-bbd1-d237120056c49
311296levoFLOXacin 750 MG Oral TabletPSNb43e9b51-568c-4d84-bbd1-d237120056c49
199884levofloxacin 250 MG Oral TabletSCDb43e9b51-568c-4d84-bbd1-d237120056c49
199885levofloxacin 500 MG Oral TabletSCDb43e9b51-568c-4d84-bbd1-d237120056c49
311296levofloxacin 750 MG Oral TabletSCDb43e9b51-568c-4d84-bbd1-d237120056c49
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYb43e9b51-568c-4d84-bbd1-d237120056c49
311296levoFLOXacin 750 MG Oral TabletPSN50c45523-1fae-4b26-e054-00144ff88e886
311296levoFLOXacin 750 MG Oral TabletPSN95149cfb-1a71-42b7-b50d-9a2e943343396
311296levoFLOXacin 750 MG Oral TabletPSNb001d60e-b8fb-54ff-e053-2a95a90a29706
311296levofloxacin 750 MG Oral TabletSCD50c45523-1fae-4b26-e054-00144ff88e886
311296levofloxacin 750 MG Oral TabletSCD95149cfb-1a71-42b7-b50d-9a2e943343396
311296levofloxacin 750 MG Oral TabletSCDb001d60e-b8fb-54ff-e053-2a95a90a29706
311296levoFLOXacin 750 MG Oral TabletPSN631523e7-7d67-0cc3-e053-2a91aa0abb625
311296levoFLOXacin 750 MG Oral TabletPSNdabedb15-5b55-3853-e053-2995a90aa44e5
311296levofloxacin 750 MG Oral TabletSCDdabedb15-5b55-3853-e053-2995a90aa44e5
311296levofloxacin 750 MG Oral TabletSCD631523e7-7d67-0cc3-e053-2a91aa0abb625
311296levoFLOXacin 750 MG Oral TabletPSN8423b021-e09c-4f1c-e053-2991aa0afef64
311296levoFLOXacin 750 MG Oral TabletPSN2a8676a9-247f-4fdb-b644-e9785d98771f4
311296levofloxacin 750 MG Oral TabletSCD8423b021-e09c-4f1c-e053-2991aa0afef64
311296levofloxacin 750 MG Oral TabletSCD2a8676a9-247f-4fdb-b644-e9785d98771f4
311296levoFLOXacin 750 MG Oral TabletPSNc6027cde-b9fe-e593-e053-2995a90ac2c12
311296levofloxacin 750 MG Oral TabletSCDc6027cde-b9fe-e593-e053-2995a90ac2c12
311296levoFLOXacin 750 MG Oral TabletPSN46a3c619-b2a3-3f28-e063-6394a90a23091
311296levofloxacin 750 MG Oral TabletSCD46a3c619-b2a3-3f28-e063-6394a90a23091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-723-203172207232020 TABLET, FILM COATED in 1 BOTTLE (31722-723-20) 2015-01-090000-00-00NoNoCurrent
31722-723-313172207233110 TABLET, FILM COATED in 1 BLISTER PACK (31722-723-31) 2015-01-090000-00-00NoNoCurrent
31722-723-3231722072332100 TABLET, FILM COATED in 1 BLISTER PACK (31722-723-32) 2015-01-090000-00-00NoNoCurrent