Moxifloxacin

Product NDC
17478-519
11-digit product format
174780519
Labeler code
17478
Product ID
17478-519_ac59ac51-425b-4bbd-bb9b-17950a9701b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA202916
Marketing category
ANDA
Marketing start
2017-11-09
Marketing end
0000-00-00
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17478-519IInactivated by FDA2026-08-17
excluded packagepackage17478-51917478-519-19IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17478-519-19d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17478-519-19f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17478-519-192ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17478-519-19a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17478-519-19cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17478-519-19cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17478-519-19302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17478-519-19ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17478-519-190efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17478-519-19ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17478-519-19367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17478-519-19557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17478-519-198af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17478-519-19834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17478-519-191332a3947898…d4bfe170f9cd…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202916-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2017-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202916-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-11-09e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202916-001AT115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202916-001AT115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202916-001AT114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202916-001AT1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202916-001AT11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202916-001AT11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202916-001AT1187673890dc5c…
2021-03-12 10:30 UTC2021-03A202916-001AT115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202916-001AT118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202916-001AT11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202916-001AT113f01610625f2…
2019-09-15 20:21 UTC2019-09A202916-001AT11b00525d2431f…
2019-07-19 19:46 UTC2019-07A202916-001AT11ea99ee380514…
2023-01-26 05:58 UTC2023-01A202916-001AT113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202916-001AT113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202916-001AT11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202916-001AT11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202916-001AT11cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-519-19Moxifloxacin1 in 1 CARTONSOLUTION/ DROPS14
17478-519-19Moxifloxacin3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-519-19ML - Milliliter17478-5192352e498-78f4-4fb8-a472-bcb6228c226012017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-519MOXIFLOXACIN SOLUTION/ DROPS [AKORN]4Legacy NDC, 2 package rows20220203_7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOXIFLOXACINMOXIFLOXACINDirect Rxd9b6a460-6377-76d0-e053-2995a90a3d052025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202916
application number: ANDA202916

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe084
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe084
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe084
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNd9b6a460-6377-76d0-e053-2995a90a3d052
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDd9b6a460-6377-76d0-e053-2995a90a3d052
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYd9b6a460-6377-76d0-e053-2995a90a3d052
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNccc845e1-0a90-4c74-8659-4d798d8cf7521
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDccc845e1-0a90-4c74-8659-4d798d8cf7521
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYccc845e1-0a90-4c74-8659-4d798d8cf7521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-519-19174780519191 BOTTLE, DROPPER in 1 CARTON (17478-519-19) > 3 mL in 1 BOTTLE, DROPPER2017-11-090000-00-00NoNoCurrent