LEVOFLOXACIN

Product NDC
0409-0528
11-digit product format
004090528
Labeler code
0409
Product ID
0409-0528_5ab673d0-89b8-410e-81ac-d18df31b6819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOFLOXACIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA078579
Marketing category
ANDA
Marketing start
2017-06-12
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-0528DDiscontinued by firm2026-10-16
excluded packagepackage0409-05280409-0528-15DDiscontinued by firm2026-10-16
excluded packagepackage0409-05280409-0528-25DDiscontinued by firm2026-10-16
excluded packagepackage0409-05280409-0528-35DDiscontinued by firm2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03
A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03
A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078579-001AP
A078579-002AP
A078579-003AP

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03c2088c7a36db…
2026-10-15 13:18:302026-09A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03c2088c7a36db…
2026-10-15 13:18:302026-09A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03c2088c7a36db…
2026-09-14 22:38:342026-08A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0384e616aacf4f…
2026-09-14 22:38:342026-08A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0384e616aacf4f…
2026-09-14 22:38:342026-08A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0384e616aacf4f…
2026-08-18 06:07:402026-07A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A078579-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A078579-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078579-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2015-09-0379d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078579-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078579-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078579-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078579-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078579-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078579-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078579-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078579-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078579-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078579-002AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078579-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078579-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078579-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078579-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078579-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078579-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078579-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078579-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078579-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078579-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078579-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078579-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078579-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078579-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078579-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078579-003AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078579-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078579-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078579-003AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078579-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078579-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078579-003AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A078579-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078579-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078579-003AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078579-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078579-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078579-003AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078579-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078579-002AP1c0c555d07b60…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0528-13ML - Milliliter0409-0528013298df-7b8b-4f7f-b569-f242723b8f9212017-05-03
0409-0528-15ML - Milliliter0409-052897f8a2ab-60be-400d-a5ee-87ec35a1588212017-05-03
0409-0528-23ML - Milliliter0409-052897b3e06a-c996-4acd-9c5d-a65daa28484c12017-05-03
0409-0528-25ML - Milliliter0409-0528d0ae828a-16ed-4696-a35c-efff56be261c12017-05-03
0409-0528-31ML - Milliliter0409-05283a48fd93-1a4e-46a6-b05c-e1aff56a85c112017-05-03
0409-0528-35ML - Milliliter0409-05287b0182fe-f9ed-4be4-84a6-99727eea713e12017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-0528-150040905281524 POUCH in 1 CASE (0409-0528-15) > 1 BAG in 1 POUCH > 50 mL in 1 BAG (0409-0528-13) 24 pouch2017-06-120000-00-00NoNoCurrent
0409-0528-250040905282524 POUCH in 1 CASE (0409-0528-25) > 1 BAG in 1 POUCH > 100 mL in 1 BAG (0409-0528-23) 24 pouch2017-06-120000-00-00NoNoCurrent
0409-0528-350040905283524 POUCH in 1 CASE (0409-0528-35) > 1 BAG in 1 POUCH > 150 mL in 1 BAG (0409-0528-31) 24 pouch2017-06-120000-00-00NoNoCurrent