Moxifloxacin

Product NDC
80425-0379
11-digit product format
804250379
Labeler code
80425
Product ID
80425-0379_14307586-424f-091a-e063-6394a90aee1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA202867
Marketing category
ANDA
Marketing start
2024-03-21
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
A202867-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202867-001AT1

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 06:07:402026-07A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-043f01610625f2…
2019-09-15 20:21 UTC2019-09A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202867-001MOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT12014-09-04e64feba35796…

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 06:07:402026-07A202867-001AT11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202867-001AT11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202867-001AT1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202867-001AT116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202867-001AT11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202867-001AT11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202867-001AT1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202867-001AT112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202867-001AT115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202867-001AT11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202867-001AT11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202867-001AT1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202867-001AT11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202867-001AT111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202867-001AT118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202867-001AT115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202867-001AT115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202867-001AT114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202867-001AT1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202867-001AT11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202867-001AT11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202867-001AT1187673890dc5c…
2021-03-12 10:30 UTC2021-03A202867-001AT115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202867-001AT118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202867-001AT11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202867-001AT113f01610625f2…
2019-09-15 20:21 UTC2019-09A202867-001AT11b00525d2431f…
2019-07-19 19:46 UTC2019-07A202867-001AT11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202867-001AT116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202867-001AT111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202867-001AT11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202867-001AT11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202867-001AT119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202867-001AT11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202867-001AT113f0d92c62455…
2023-05-13 08:27 UTC2023-05A202867-001AT11053a50430f4f…
2023-01-26 05:58 UTC2023-01A202867-001AT113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202867-001AT113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202867-001AT11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202867-001AT11e64feba35796…

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
143075b4-24d4-08a1-e063-6394a90a8a6eAvailable 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
80425-0379-1Moxifloxacin1 in 1 CARTONSOLUTION/ DROPS11
80425-0379-1Moxifloxacin3 mL in 1 BOTTLESOLUTION/ DROPS31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0379-1ML - Milliliter80425-03792b043e05-cce8-4154-9e72-668325874d2f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0379MOXIFLOXACIN SOLUTION/ DROPS [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 2 package rows20240322_143075b4-24d4-08a1-e063-6394a90a8a6e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MoxifloxacinMOXIFLOXACINRedpharm Drug301eef74-16db-14aa-e063-6294a90ac8ff2025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202867
application number: ANDA202867
MoxifloxacinMOXIFLOXACINLupin Pharmaceuticals, Inc.ae77e219-8af9-4aa4-96d3-05c9726a1d3c2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202867
application number: ANDA202867
MOXIFLOXACINMOXIFLOXACINDirect Rxd771e69b-7d9b-13fa-e053-2995a90ac1612025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202867
application number: ANDA202867
MoxifloxacinMOXIFLOXACINAdvanced Rx Pharmacy of Tennessee, LLC143075b4-24d4-08a1-e063-6394a90a8a6e2024-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202867
application number: ANDA202867
ndc (product): 80425-0379
MoxifloxacinMOXIFLOXACINA-S Medication Solutions4dee7a26-25e2-4ce9-8fd2-e8c3ac6ef5ff2023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202867
application number: ANDA202867

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSN143075b4-24d4-08a1-e063-6394a90a8a6e1
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCD143075b4-24d4-08a1-e063-6394a90a8a6e1
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSY143075b4-24d4-08a1-e063-6394a90a8a6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0379-1804250379011 BOTTLE in 1 CARTON (80425-0379-1) / 3 mL in 1 BOTTLE1 bottle2024-03-21NoNoCurrent