FDA.reportPublic FDA data

Levaquin

Product NDC
50458-920
11-digit product format
504580920
Labeler code
50458
Product ID
50458-920_a50d49b4-6387-11ea-99f1-bb04fc2ca371
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA020634
Marketing category
NDA
Marketing start
1996-12-20
Marketing end
2021-01-22
Substance
LEVOFLOXACIN
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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
50458-920-10EA - Each50458-920b3c3e262-0c30-4e70-bcd5-79359b65325812012-07-24
50458-920-50EA - Each50458-920b9f5bc91-31ed-40d4-bb35-94b465467aac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
levofloxacinACTIVE MOIETY6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [REDPHARM DRUG INC.]2
levofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
levofloxacinACTIVE MOIETY6GNT3Y5LMFLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
crospovidoneINACTIVE INGREDIENT68401960MKLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211815LEVAQUIN 250 MG Oral TabletPSN139f86a4-75c5-4304-894c-8f8b8a396c782
199884levoFLOXacin 250 MG Oral TabletPSN139f86a4-75c5-4304-894c-8f8b8a396c782
211815levofloxacin 250 MG Oral Tablet [Levaquin]SBD139f86a4-75c5-4304-894c-8f8b8a396c782
199884levofloxacin 250 MG Oral TabletSCD139f86a4-75c5-4304-894c-8f8b8a396c782
211815Levaquin 250 MG Oral TabletSY139f86a4-75c5-4304-894c-8f8b8a396c782
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY139f86a4-75c5-4304-894c-8f8b8a396c782
211815LEVAQUIN 250 MG Oral TabletPSN5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
211816LEVAQUIN 500 MG Oral TabletPSN5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
284481LEVAQUIN 750 MG Oral TabletPSN5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
199884levoFLOXacin 250 MG Oral TabletPSN5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
199885levoFLOXacin 500 MG Oral TabletPSN5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
311296levoFLOXacin 750 MG Oral TabletPSN5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
211815levofloxacin 250 MG Oral Tablet [Levaquin]SBD5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
211816levofloxacin 500 MG Oral Tablet [Levaquin]SBD5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
284481levofloxacin 750 MG Oral Tablet [Levaquin]SBD5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
199884levofloxacin 250 MG Oral TabletSCD5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
199885levofloxacin 500 MG Oral TabletSCD5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
311296levofloxacin 750 MG Oral TabletSCD5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
211815Levaquin 250 MG Oral TabletSY5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
211816Levaquin 500 MG Oral TabletSY5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
284481Levaquin 750 MG Oral TabletSY5dd1f9bb-acbf-4deb-9b02-992d52239a6b1
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY5dd1f9bb-acbf-4deb-9b02-992d52239a6b1