Levofloxacin

Product NDC
70518-0719
11-digit product format
705180719
Labeler code
70518
Product ID
70518-0719_48332f2b-f97c-f9fd-e063-6394a90affa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202801
Marketing category
ANDA
Marketing start
2017-08-30
Substance
LEVOFLOXACIN
Active strength
250 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
LEVOFLOXACIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884

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
70518-0719-0Levofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0719LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 1 package rows20250523_b8ac5047-5203-42c4-886b-dd0b08a1786f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSNb8ac5047-5203-42c4-886b-dd0b08a1786f16
199884levofloxacin 250 MG Oral TabletSCDb8ac5047-5203-42c4-886b-dd0b08a1786f16
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYb8ac5047-5203-42c4-886b-dd0b08a1786f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0719-07051807190030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0719-0) 2017-08-300000-00-00NoNoCurrent