Levofloxacin

Product NDC
44567-435
11-digit product format
445670435
Labeler code
44567
Product ID
44567-435_e6bfbccc-f54c-4d4d-b268-b4fc803e372b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA090343
Marketing category
ANDA
Marketing start
2016-04-14
Substance
LEVOFLOXACIN
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07
A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07
A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090343-001AP
A090343-002AP
A090343-003AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090343-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090343-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090343-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAPRS2011-07-071e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090343-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A090343-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A090343-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090343-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090343-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090343-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090343-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090343-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090343-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090343-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090343-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090343-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090343-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090343-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090343-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090343-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090343-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090343-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090343-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090343-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090343-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090343-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090343-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090343-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090343-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090343-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090343-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090343-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090343-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090343-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090343-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090343-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090343-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090343-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090343-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090343-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090343-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090343-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090343-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090343-001AP11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6GNT3Y5LMFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1665497Internal RxNorm lookup
1665507Internal RxNorm lookup
1665515Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9020cdeb-65fe-458f-bbbd-69265a49906eAvailable on FDA.report

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
44567-435-24Levofloxacin24 in 1 CARTONINJECTION, SOLUTION2411
44567-435-24Levofloxacin1 in 1 POUCHINJECTION, SOLUTION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-435LEVOFLOXACIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]11Current NDC, Legacy NDC, 2 package rows20250206_9020cdeb-65fe-458f-bbbd-69265a49906e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINSagent Pharmaceuticals699fbdb8-a6fd-476a-9b80-08197d8695342026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090343
application number: ANDA090343
LevofloxacinLEVOFLOXACINHospira, Inc5a1534af-aa1c-4f1d-ba9f-9415b14e1af22025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090343
application number: ANDA090343
LevofloxacinLEVOFLOXACINWG Critical Care, LLC9020cdeb-65fe-458f-bbbd-69265a49906e2024-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090343
application number: ANDA090343
ndc (product): 44567-435

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665497levoFLOXacin 250 MG in 50 ML InjectionPSN9020cdeb-65fe-458f-bbbd-69265a49906e11
1665507levoFLOXacin 500 MG in 100 ML InjectionPSN9020cdeb-65fe-458f-bbbd-69265a49906e11
1665515levoFLOXacin 750 MG in 150 ML InjectionPSN9020cdeb-65fe-458f-bbbd-69265a49906e11
1665507100 ML levofloxacin 5 MG/ML InjectionSCD9020cdeb-65fe-458f-bbbd-69265a49906e11
1665515150 ML levofloxacin 5 MG/ML InjectionSCD9020cdeb-65fe-458f-bbbd-69265a49906e11
166549750 ML levofloxacin 5 MG/ML InjectionSCD9020cdeb-65fe-458f-bbbd-69265a49906e11
1665497levofloxacin 250 MG per 50 ML InjectionSY9020cdeb-65fe-458f-bbbd-69265a49906e11
1665507levofloxacin 500 MG per 100 ML InjectionSY9020cdeb-65fe-458f-bbbd-69265a49906e11
1665515levofloxacin 750 MG per 150 ML InjectionSY9020cdeb-65fe-458f-bbbd-69265a49906e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-435-244456704352424 POUCH in 1 CARTON (44567-435-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG24 pouch2016-04-140000-00-00NoNoCurrent