Levofloxacin

Product NDC
63187-438
11-digit product format
631870438
Labeler code
63187
Product ID
63187-438_42b9c689-6cdb-4667-ae4e-98cef35d1f8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200839
Marketing category
ANDA
Marketing start
2012-03-22
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-438-03EA - Each63187-4384c3ef548-3b81-4535-b240-c33f5f057fcc12021-07-15
63187-438-05EA - Each63187-43867a30bb8-b709-411f-a342-5993a7d4b5d412017-06-15
63187-438-07EA - Each63187-438b95be296-6a2f-4c75-a28c-872c1e58c55912017-11-06
63187-438-10EA - Each63187-4387efcefe3-0af4-4f73-932a-393bcd96934b12016-02-04
63187-438-14EA - Each63187-438d485faf5-c544-4d5a-a252-13bffa694b3212023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-438LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]7Legacy NDC20220513_2cb16f61-390f-4365-9c42-b21d87e469e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-438-03631870438033 TABLET, FILM COATED in 1 BOTTLE (63187-438-03) 2021-05-190000-00-00NoNoCurrent
63187-438-05631870438055 TABLET, FILM COATED in 1 BOTTLE (63187-438-05) 2019-01-010000-00-00NoNoCurrent
63187-438-07631870438077 TABLET, FILM COATED in 1 BLISTER PACK (63187-438-07) 2019-01-010000-00-00NoNoCurrent
63187-438-106318704381010 TABLET, FILM COATED in 1 BLISTER PACK (63187-438-10) 2019-01-010000-00-00NoNoCurrent
63187-438-146318704381414 TABLET, FILM COATED in 1 BOTTLE (63187-438-14) 2019-01-010000-00-00NoNoCurrent
63187-438-306318704383030 TABLET, FILM COATED in 1 BOTTLE (63187-438-30) 2019-01-010000-00-00NoNoCurrent