Home NDC 0781-7135 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021598-001 VIGAMOX MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021598-001 AT1
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021598-001 VIGAMOX EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT1 RLD, RS 2003-04-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021598-001 6716830 2019-09-29 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021598-001 7671070 2019-09-29 U-709 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021598-001 6716830*PED 2020-03-29 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021598-001 7671070*PED 2020-03-29 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021598-001 6716830*PED 2020-03-29 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021598-001 7671070*PED 2020-03-29 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021598-001 6716830*PED 2020-03-29 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021598-001 7671070*PED 2020-03-29 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021598-001 6716830 2019-09-29 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021598-001 7671070 2019-09-29 U-709 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021598-001 6716830*PED 2020-03-29 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021598-001 7671070*PED 2020-03-29 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021598-001 6716830 2019-09-29 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021598-001 7671070 2019-09-29 U-709 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021598-001 6716830*PED 2020-03-29 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021598-001 7671070*PED 2020-03-29 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021598-001 6716830 2019-09-29 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021598-001 7671070 2019-09-29 U-709 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021598-001 6716830*PED 2020-03-29 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021598-001 7671070*PED 2020-03-29 Pediatric extension ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Moxifloxacin Ophthalmic Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C53598599T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403818 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-7135-93 Moxifloxacin Ophthalmic Solution 1 in 1 CARTON SOLUTION/ DROPS 1 3 0781-7135-93 Moxifloxacin Ophthalmic Solution 3 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-7135 MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION/ DROPS [SANDOZ INC] 3 Current NDC, Legacy NDC, 2 package rows 20200714_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-7135-93 00781713593 1 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) / 3 mL in 1 BOTTLE, PLASTIC 2017-06-30 0000-00-00 No No Current