FDA.reportPublic FDA data

Levofloxacin

Product NDC
0143-9721
11-digit product format
001439721
Labeler code
0143
Product ID
0143-9721_27201c72-46ca-4507-8333-00e8ec582ba0
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
500 mg/100mL
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
LEVOFLOXACIN500 mg/100mL

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
0143-9721-01Levofloxacin100 mL in 1 BAGINJECTION, SOLUTION10012
0143-9721-24Levofloxacin24 in 1 CARTONINJECTION, SOLUTION2412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9721-01ML - Milliliter0143-97214f7ffbd1-d911-4ec3-b828-3cd7ff9fc0f712013-02-13
0143-9721-24ML - Milliliter0143-97211d2bf451-0858-4573-afa9-f7bf8356056c12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GLEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9721LEVOFLOXACIN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 2 package rows20190329_e680c759-16c5-4532-9c9c-f42c8c3df74a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665497levoFLOXacin 250 MG in 50 ML InjectionPSNe680c759-16c5-4532-9c9c-f42c8c3df74a12
1665507levoFLOXacin 500 MG in 100 ML InjectionPSNe680c759-16c5-4532-9c9c-f42c8c3df74a12
1665515levoFLOXacin 750 MG in 150 ML InjectionPSNe680c759-16c5-4532-9c9c-f42c8c3df74a12
1665507100 ML levofloxacin 5 MG/ML InjectionSCDe680c759-16c5-4532-9c9c-f42c8c3df74a12
1665515150 ML levofloxacin 5 MG/ML InjectionSCDe680c759-16c5-4532-9c9c-f42c8c3df74a12
166549750 ML levofloxacin 5 MG/ML InjectionSCDe680c759-16c5-4532-9c9c-f42c8c3df74a12
1665497levofloxacin 250 MG per 50 ML InjectionSYe680c759-16c5-4532-9c9c-f42c8c3df74a12
1665507levofloxacin 500 MG per 100 ML InjectionSYe680c759-16c5-4532-9c9c-f42c8c3df74a12
1665515levofloxacin 750 MG per 150 ML InjectionSYe680c759-16c5-4532-9c9c-f42c8c3df74a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9721-0100143972101100 mL in 1 BAG100 mlHistorical
0143-9721-240014397212424 BAG in 1 CARTON (0143-9721-24) / 100 mL in 1 BAG (0143-9721-01) 24 bag2011-09-160000-00-00NoNoCurrent