Moxifloxacin Ophthalmic Solution

Product NDC
0781-7135
11-digit product format
007817135
Labeler code
0781
Product ID
0781-7135_fe09f635-c4f0-4698-8468-d226257b6d58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA021598
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-05-07
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [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
N021598-001VIGAMOXMOXIFLOXACIN HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021598-001AT1

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 06:07:402026-07N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-153f01610625f2…
2019-09-15 20:21 UTC2019-09N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021598-001VIGAMOXEQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT1RLD, RS2003-04-15e64feba35796…

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 06:07:402026-07N021598-001AT11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021598-001AT11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021598-001AT1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021598-001AT116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021598-001AT11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021598-001AT11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021598-001AT1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021598-001AT112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021598-001AT115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021598-001AT11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021598-001AT11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021598-001AT1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021598-001AT11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021598-001AT111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021598-001AT118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021598-001AT115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021598-001AT115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021598-001AT114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021598-001AT1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021598-001AT11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021598-001AT11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021598-001AT1187673890dc5c…
2021-03-12 10:30 UTC2021-03N021598-001AT115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021598-001AT118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021598-001AT11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021598-001AT113f01610625f2…
2019-09-15 20:21 UTC2019-09N021598-001AT11b00525d2431f…
2019-07-19 19:46 UTC2019-07N021598-001AT11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021598-001AT116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021598-001AT111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021598-001AT11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021598-001AT11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021598-001AT119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021598-001AT11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021598-001AT113f0d92c62455…
2023-05-13 08:27 UTC2023-05N021598-001AT11053a50430f4f…
2023-01-26 05:58 UTC2023-01N021598-001AT113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021598-001AT113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021598-001AT11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021598-001AT11e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021598-00167168302019-09-29Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021598-00176710702019-09-29U-70974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021598-0016716830*PED2020-03-29Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021598-0017671070*PED2020-03-29Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021598-0016716830*PED2020-03-29Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021598-0017671070*PED2020-03-29Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021598-0016716830*PED2020-03-29Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021598-0017671070*PED2020-03-29Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021598-00167168302019-09-29Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021598-00176710702019-09-29U-7093f01610625f2…
2019-12-14 00:12 UTC2019-12N021598-0016716830*PED2020-03-29Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021598-0017671070*PED2020-03-29Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021598-00167168302019-09-29Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021598-00176710702019-09-29U-709b00525d2431f…
2019-09-15 20:21 UTC2019-09N021598-0016716830*PED2020-03-29Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021598-0017671070*PED2020-03-29Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021598-00167168302019-09-29Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021598-00176710702019-09-29U-709ea99ee380514…
2019-07-19 19:46 UTC2019-07N021598-0016716830*PED2020-03-29Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021598-0017671070*PED2020-03-29Pediatric extensionea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOXIFLOXACIN HYDROCHLORIDE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C53598599TInternal 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
fc88791b-24da-48a4-85f5-93a8af3d0b51Available 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
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
0781-7135-93Moxifloxacin Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS13
0781-7135-93Moxifloxacin Ophthalmic Solution3 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7135-93ML - Milliliter0781-713587b77896-4559-469b-b804-f2efcebdd7cd12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7135MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION/ DROPS [SANDOZ INC]3Current NDC, Legacy NDC, 2 package rows20200714_fc88791b-24da-48a4-85f5-93a8af3d0b51.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIGAMOXMOXIFLOXACIN HYDROCHLORIDEHarrow Eye, LLC12053b08-7e66-c6f3-e063-6394a90a9cd92026-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 021598
application number: NDA021598
Moxifloxacin Ophthalmic SolutionMOXIFLOXACIN HYDROCHLORIDESandoz Incfc88791b-24da-48a4-85f5-93a8af3d0b512020-06-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021598
application number: NDA021598
ndc (product): 0781-7135

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403818moxifloxacin HCl 0.5 % Ophthalmic SolutionPSNfc88791b-24da-48a4-85f5-93a8af3d0b513
403818moxifloxacin 5 MG/ML Ophthalmic SolutionSCDfc88791b-24da-48a4-85f5-93a8af3d0b513
403818moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic SolutionSYfc88791b-24da-48a4-85f5-93a8af3d0b513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-7135-93007817135931 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) / 3 mL in 1 BOTTLE, PLASTIC2017-06-300000-00-00NoNoCurrent