MOXIFLOXACIN

Product NDC
72189-076
Requested package NDC
72189-076-05
11-digit product format
721890076
Labeler code
72189
Product ID
72189-076_9ffa08ea-c456-80b7-e053-2a95a90a4bd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOXIFLOXACIN
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA206242
Marketing category
ANDA
Marketing start
2020-03-04
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72189-07672189-076-05IInactivated by FDA2026-09-14

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206242-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206242-001AT1

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-0484e616aacf4f…
2026-08-18 06:07:402026-07A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-043f01610625f2…
2019-09-15 20:21 UTC2019-09A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206242-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-10-04f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206242-001AT1184e616aacf4f…
2026-08-18 06:07:402026-07A206242-001AT11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206242-001AT11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206242-001AT1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206242-001AT116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206242-001AT11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206242-001AT11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206242-001AT1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206242-001AT112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206242-001AT115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206242-001AT11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206242-001AT11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206242-001AT1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206242-001AT11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206242-001AT111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206242-001AT118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206242-001AT115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206242-001AT115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206242-001AT114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206242-001AT1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206242-001AT11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206242-001AT11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206242-001AT1187673890dc5c…
2021-03-12 10:30 UTC2021-03A206242-001AT115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206242-001AT118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206242-001AT11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206242-001AT113f01610625f2…
2019-09-15 20:21 UTC2019-09A206242-001AT11b00525d2431f…
2019-07-19 19:46 UTC2019-07A206242-001AT11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206242-001AT116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206242-001AT111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206242-001AT11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206242-001AT11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206242-001AT119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206242-001AT11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206242-001AT113f0d92c62455…
2023-05-13 08:27 UTC2023-05A206242-001AT11053a50430f4f…
2023-01-26 05:58 UTC2023-01A206242-001AT113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206242-001AT113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206242-001AT11f41ea6bd6efb…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-076-052023-01-30C16284748780-1f386c64a-0457-0266-e053-dadaa90a7c1aMOXIFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-076-05MOXIFLOXACIN3 mL in 1 BOTTLESOLUTION/ DROPS31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-076-05ML - Milliliter72189-076cfc145a4-0c80-4031-a1fa-d48555acb1b712020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-076MOXIFLOXACIN SOLUTION/ DROPS [DIRECT RX]1Legacy NDC, 1 package rows20200305_9ffa08ea-c455-80b7-e053-2a95a90a4bd6.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOXIFLOXACINMOXIFLOXACINA-S Medication Solutionsf702e112-b037-4e50-ac30-b1d27fc0e30e2026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206242
application number: ANDA206242
MOXIFLOXACINMOXIFLOXACINAurobindo Pharma Limited8877013d-9b49-40f7-a2c4-99bb519e104e2024-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206242
application number: ANDA206242
MOXIFLOXACINMOXIFLOXACINProficient Rx LPc38e051f-5765-4066-9953-2d0832481b1e2024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206242
application number: ANDA206242
MOXIFLOXACINMOXIFLOXACINNorthStar Rx LLCcdc0b0eb-5f56-45c7-b9fd-364752a95ff12022-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206242
application number: ANDA206242

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN9ffa08ea-c455-80b7-e053-2a95a90a4bd61
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD9ffa08ea-c455-80b7-e053-2a95a90a4bd61
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY9ffa08ea-c455-80b7-e053-2a95a90a4bd61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-076-05721890076053 mL in 1 BOTTLE (72189-076-05) 3 ml2020-03-040000-00-00NoNoCurrent