FDA.reportPublic FDA data

Levofloxacin

Product NDC
51655-327
11-digit product format
516550327
Labeler code
51655
Product ID
51655-327_48eb0bd1-3a7e-3ba5-e063-6294a90a98c3
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
2022-11-28
Substance
LEVOFLOXACIN
Active strength
750 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
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
51655-327-07Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED74
51655-327-53Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED104
51655-327-55Levofloxacin5 in 1 BOTTLE, PLASTICTABLET, FILM COATED54
51655-327-84Levofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-327LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 4 package rows20240220_f2f090c2-3ee1-7689-e053-2995a90abe38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSNf2f090c2-3ee1-7689-e053-2995a90abe384
311296levofloxacin 750 MG Oral TabletSCDf2f090c2-3ee1-7689-e053-2995a90abe384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-327-07516550327077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-07) 2023-02-20NoNoHistorical
51655-327-535165503275310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-53) 2023-03-20NoNoHistorical
51655-327-55516550327555 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-55) 2022-11-28NoNoHistorical
51655-327-845165503278414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-327-84) 2024-01-19NoNoHistorical