Home NDC 59390-140 Ofloxacin ophthalmic
Product NDC 59390-140
11-digit product format 593900140
Labeler code 59390
Product ID 59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ofloxacin
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Altaire Pharmaceuticals Inc.
Application ANDA202692
Marketing category ANDA
Marketing start 2013-05-31
Substance OFLOXACIN
Active strength 3 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 1 .
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 A202692-001 OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202692-001 AT
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202692-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2013-04-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ofloxacin ophthalmic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OFLOXACIN 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A4P49JAZ9H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312075 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59390-140-05 Ofloxacin ophthalmic 5 mL in 1 BOTTLE, DROPPER SOLUTION 5 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59390-140 OFLOXACIN OPHTHALMIC (OFLOXACIN) SOLUTION [ALTAIRE PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 1 package rows 20221101_fe564e33-8f5d-4b57-87a9-7afae02eaf97.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59390-140-05 59390014005 5 mL in 1 BOTTLE, DROPPER (59390-140-05) 5 ml 2013-05-31 0000-00-00 No No Current