Levofloxacin

Product NDC
0143-9317
11-digit product format
001439317
Labeler code
0143
Product ID
0143-9317_05cdb9d7-2bce-400d-8565-8a76c4a1a8e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA091375
Marketing category
ANDA
Marketing start
2011-09-16
Substance
LEVOFLOXACIN
Active strength
750 mg/150mL
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/150mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui1665497, 1665507, 1665515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9317-01Levofloxacin150 mL in 1 BAGINJECTION, SOLUTION1505
0143-9317-24Levofloxacin24 in 1 CARTONINJECTION, SOLUTION245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9317-01ML - Milliliter0143-9317303c177d-66cf-41db-a050-8946898b99f612018-12-13
0143-9317-24ML - Milliliter0143-931775e047e5-4ac9-43f1-9dbf-856737ef512d12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9317LEVOFLOXACIN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20190329_f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665497levoFLOXacin 250 MG in 50 ML InjectionPSNf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55
1665507levoFLOXacin 500 MG in 100 ML InjectionPSNf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55
1665515levoFLOXacin 750 MG in 150 ML InjectionPSNf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55
1665507100 ML levofloxacin 5 MG/ML InjectionSCDf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55
1665515150 ML levofloxacin 5 MG/ML InjectionSCDf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55
166549750 ML levofloxacin 5 MG/ML InjectionSCDf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55
1665497levofloxacin 250 MG per 50 ML InjectionSYf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55
1665507levofloxacin 500 MG per 100 ML InjectionSYf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55
1665515levofloxacin 750 MG per 150 ML InjectionSYf23c0df4-ae2a-446c-a9ba-dbbeb6ffaba55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9317-0100143931701150 mL in 1 BAG150 mlHistorical
0143-9317-240014393172424 BAG in 1 CARTON (0143-9317-24) / 150 mL in 1 BAG (0143-9317-01) 24 bag2011-09-160000-00-00NoNoCurrent