Levofloxacin

Product NDC
54348-611
11-digit product format
543480611
Labeler code
54348
Product ID
54348-611_8f767d54-b0e5-4d9a-e053-2995a90a2999
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOFLOXACIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA200839
Marketing category
ANDA
Marketing start
2019-07-12
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54348-611-072023-05-18C16284748780-1f386c649-e44b-0266-e053-dadaa90a7c1afb442549-d856-494a-a2e1-263139877214
54348-611-072023-01-30C16284748780-1f386c649-e44b-0266-e053-dadaa90a7c1afb442549-d856-494a-a2e1-263139877214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-611-07543480611071 BOTTLE in 1 BOX (54348-611-07) > 7 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-120000-00-00NoNoCurrent