FDA.reportPublic FDA data

Levofloxacin

Product NDC
72789-248
11-digit product format
727890248
Labeler code
72789
Product ID
72789-248_2bad21ae-f086-92a5-e063-6294a90adce0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx 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
Rxcui311296

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
72789-248-05Levofloxacin5 in 1 BOTTLE, PLASTICTABLET, FILM COATED514
72789-248-07Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED714
72789-248-10Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-248-05EA - Each72789-248d5bb58ed-2453-4b22-910d-8c5da253249912022-08-04
72789-248-07EA - Each72789-248ca277185-b157-42e6-847f-7948cd28fd9612022-05-04
72789-248-10EA - Each72789-2489973e6da-f3b8-4c0d-9411-032348c0a4c512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-248LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 3 package rows20250115_d98cf024-51fa-45a1-b247-da55aba88ca0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSNd98cf024-51fa-45a1-b247-da55aba88ca014
311296levofloxacin 750 MG Oral TabletSCDd98cf024-51fa-45a1-b247-da55aba88ca014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-248-05727890248055 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-248-05) 2022-06-210000-00-00NoNoCurrent
72789-248-07727890248077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-248-07) 2022-04-210000-00-00NoNoCurrent
72789-248-107278902481010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-248-10) 2022-04-260000-00-00NoNoCurrent