Levofloxacin

Product NDC
51655-947
11-digit product format
516550947
Labeler code
51655
Product ID
51655-947_49748fcf-7277-a6ad-e063-6394a90a1107
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076710
Marketing category
ANDA
Marketing start
2023-02-21
Substance
LEVOFLOXACIN
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884

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
51655-947-53Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-947LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230404_f780bb91-483a-d1a6-e053-6294a90ab74b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSNf780bb91-483a-d1a6-e053-6294a90ab74b2
199884levofloxacin 250 MG Oral TabletSCDf780bb91-483a-d1a6-e053-6294a90ab74b2
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYf780bb91-483a-d1a6-e053-6294a90ab74b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-947-535165509475310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-947-53) 2023-02-21NoNoHistorical