Moxifloxacin

Product NDC
60505-0582
11-digit product format
605050582
Labeler code
60505
Product ID
60505-0582_1f0760bf-4dfb-6466-23d6-72770eecf10e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA090080
Marketing category
ANDA
Marketing start
2017-07-01
Substance
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active strength
5 mg/mL
Pharmacologic classes
Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090080-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090080-001AT1

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-303f01610625f2…
2019-09-15 20:21 UTC2019-09A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090080-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12017-06-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090080-001AT11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090080-001AT11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090080-001AT1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090080-001AT116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090080-001AT11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090080-001AT11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090080-001AT1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090080-001AT112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090080-001AT115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090080-001AT11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090080-001AT11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090080-001AT1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090080-001AT11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090080-001AT111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090080-001AT118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090080-001AT115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090080-001AT115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090080-001AT114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090080-001AT1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090080-001AT11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090080-001AT11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090080-001AT1187673890dc5c…
2021-03-12 10:30 UTC2021-03A090080-001AT115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090080-001AT118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090080-001AT11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090080-001AT113f01610625f2…
2019-09-15 20:21 UTC2019-09A090080-001AT11b00525d2431f…
2019-07-19 19:46 UTC2019-07A090080-001AT11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090080-001AT116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090080-001AT111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090080-001AT11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090080-001AT11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090080-001AT119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090080-001AT11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090080-001AT113f0d92c62455…
2023-05-13 08:27 UTC2023-05A090080-001AT11053a50430f4f…
2023-01-26 05:58 UTC2023-01A090080-001AT113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090080-001AT113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090080-001AT11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090080-001AT11e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B8956S8609Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403818Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f7a0c4c-34f4-7362-579b-f26c3338f792Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0582-4Moxifloxacin1 in 1 CARTONSOLUTION/ DROPS19
60505-0582-4Moxifloxacin3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0582-4ML - Milliliter60505-0582a48c6dfd-2171-4f1c-b8b7-dbc8490978f212017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0582MOXIFLOXACIN SOLUTION/ DROPS [APOTEX CORP.]8Current NDC, Legacy NDC, 2 package rows20240927_8f7a0c4c-34f4-7362-579b-f26c3338f792.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
MoxifloxacinMOXIFLOXACINGolden State Medical Supply, Inc.f9dff08a-edb2-86de-e053-6394a90a10432025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090080
application number: ANDA090080
MoxifloxacinMOXIFLOXACINApotex Corp.8f7a0c4c-34f4-7362-579b-f26c3338f7922025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090080
application number: ANDA090080
ndc (product): 60505-0582
MoxifloxacinMOXIFLOXACINAdvanced Rx Pharmacy of Tennessee, LLCf19fa89e-9f5d-4eed-e053-2995a90ac3ce2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090080
application number: ANDA090080
MoxifloxacinMOXIFLOXACINBryant Ranch Prepack1cc031d7-0766-41c0-b5b3-35119c850e232024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090080
application number: ANDA090080

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN1cc031d7-0766-41c0-b5b3-35119c850e23101
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD1cc031d7-0766-41c0-b5b3-35119c850e23101
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY1cc031d7-0766-41c0-b5b3-35119c850e23101
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN8f7a0c4c-34f4-7362-579b-f26c3338f7929
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD8f7a0c4c-34f4-7362-579b-f26c3338f7929
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY8f7a0c4c-34f4-7362-579b-f26c3338f7929
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNf19fa89e-9f5d-4eed-e053-2995a90ac3ce3
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN84277117-b228-41ed-a605-bcb532101c3d3
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD84277117-b228-41ed-a605-bcb532101c3d3
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDf19fa89e-9f5d-4eed-e053-2995a90ac3ce3
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY84277117-b228-41ed-a605-bcb532101c3d3
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYf19fa89e-9f5d-4eed-e053-2995a90ac3ce3
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN723771a2-3e9a-e6f3-e053-2a91aa0a4d211
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNe812cc8a-9d03-430f-bc90-07c93837e2501
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN688feb67-9254-4537-b749-9d591fef56371
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD723771a2-3e9a-e6f3-e053-2a91aa0a4d211
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDe812cc8a-9d03-430f-bc90-07c93837e2501
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD688feb67-9254-4537-b749-9d591fef56371
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY723771a2-3e9a-e6f3-e053-2a91aa0a4d211
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY688feb67-9254-4537-b749-9d591fef56371
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYe812cc8a-9d03-430f-bc90-07c93837e2501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0582-4605050582041 BOTTLE, DROPPER in 1 CARTON (60505-0582-4) / 3 mL in 1 BOTTLE, DROPPER2017-07-010000-00-00NoNoCurrent