FDA.reportPublic FDA data

Levofloxacin

Product NDC
63187-833
11-digit product format
631870833
Labeler code
63187
Product ID
63187-833_e5c99469-b1e5-4f86-b4fa-7fcb4eac8f46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
63187-833-05Levofloxacin05 in 1 BOTTLETABLET, FILM COATED056
63187-833-07Levofloxacin07 in 1 BOTTLETABLET, FILM COATED076
63187-833-10Levofloxacin10 in 1 BOTTLETABLET, FILM COATED106
63187-833-30Levofloxacin30 in 1 BOTTLETABLET, FILM COATED306
63187-833-60Levofloxacin60 in 1 BOTTLETABLET, FILM COATED606
63187-833-90Levofloxacin90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-833-05EA - Each63187-83354479980-5918-40aa-80b0-79e56472be7212018-12-13
63187-833-07EA - Each63187-833b0768ea9-56a1-414b-8d58-988bc4f5f5c412017-10-13
63187-833-10EA - Each63187-833e88d0a65-e3ec-482a-90b8-338db04f21ac12017-06-15
63187-833-30EA - Each63187-833c0e08955-9fa7-418c-aa77-b8310b3ba07012021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-833LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20220930_95149cfb-1a71-42b7-b50d-9a2e94334339.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSN95149cfb-1a71-42b7-b50d-9a2e943343396
311296levofloxacin 750 MG Oral TabletSCD95149cfb-1a71-42b7-b50d-9a2e943343396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-833-05631870833055 TABLET, FILM COATED in 1 BOTTLE (63187-833-05) 2017-05-010000-00-00NoNoCurrent
63187-833-07631870833077 TABLET, FILM COATED in 1 BOTTLE (63187-833-07) 2017-05-010000-00-00NoNoCurrent
63187-833-106318708331010 TABLET, FILM COATED in 1 BOTTLE (63187-833-10) 2017-05-010000-00-00NoNoCurrent
63187-833-306318708333030 TABLET, FILM COATED in 1 BOTTLE (63187-833-30) 2017-05-010000-00-00NoNoCurrent
63187-833-606318708336060 TABLET, FILM COATED in 1 BOTTLE (63187-833-60) 2017-05-010000-00-00NoNoCurrent
63187-833-906318708339090 TABLET, FILM COATED in 1 BOTTLE (63187-833-90) 2017-05-010000-00-00NoNoCurrent