Levofloxacin

Product NDC
43063-796
11-digit product format
430630796
Labeler code
43063
Product ID
43063-796_f0837ca3-fdb7-2a16-e053-2a95a90a40da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA200839
Marketing category
ANDA
Marketing start
2012-03-22
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-796-05EA - Each43063-7968defad82-d574-45a3-a2d7-8d21a13d410412017-11-06
43063-796-07EA - Each43063-79645b3b280-b900-4c1c-8158-de8ac540516312017-11-06
43063-796-10EA - Each43063-796cf989892-6321-430c-9476-dc1880fb8f0512018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-796LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]27Legacy NDC20241017_5f1893a6-34d7-428a-b921-6b33e05f42ad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-796-05430630796055 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-796-05) 2017-10-110000-00-00NoNoCurrent
43063-796-07430630796077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-796-07) 2017-10-110000-00-00NoNoCurrent
43063-796-104306307961010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-796-10) 2018-01-050000-00-00NoNoCurrent