FDA.reportPublic FDA data

Levofloxacin

Product NDC
0527-1948
11-digit product format
005271948
Labeler code
0527
Product ID
0527-1948_01e976a4-eb3a-4d1a-a384-46222c20afc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA205222
Marketing category
ANDA
Marketing start
2018-05-25
Substance
LEVOFLOXACIN
Active strength
25 mg/mL
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui477391

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1948-66Levofloxacin1 in 1 CARTONSOLUTION128
0527-1948-66Levofloxacin100 mL in 1 BOTTLE, PLASTICSOLUTION10028
0527-1948-68Levofloxacin200 mL in 1 BOTTLE, PLASTICSOLUTION20028
0527-1948-68Levofloxacin1 in 1 CARTONSOLUTION128
0527-1948-70Levofloxacin1 in 1 CARTONSOLUTION128
0527-1948-70Levofloxacin480 mL in 1 BOTTLE, PLASTICSOLUTION48028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1948-66ML - Milliliter0527-1948762157c0-c4d9-42aa-8f80-cdae714c692f12018-07-03
0527-1948-68ML - Milliliter0527-1948db48b5d4-52ec-4601-b60a-bb536502728c12018-07-03
0527-1948-70ML - Milliliter0527-1948532534fb-2399-4097-a52f-a2b496d645e212018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1948LEVOFLOXACIN SOLUTION [LANNETT COMPANY, INC.]27Current NDC, Legacy NDC, 6 package rows20240629_362fb864-3afb-4841-a7c4-b64b1346aba0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1948-66005271948661 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) / 100 mL in 1 BOTTLE, PLASTIC2018-05-250000-00-00NoNoCurrent
0527-1948-68005271948681 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) / 200 mL in 1 BOTTLE, PLASTIC2018-05-250000-00-00NoNoCurrent
0527-1948-70005271948701 BOTTLE, PLASTIC in 1 CARTON (0527-1948-70) / 480 mL in 1 BOTTLE, PLASTIC2018-05-250000-00-00NoNoCurrent