Home NDC 65145-207 Gatifloxacin Ophthalmic Solution 0.5%
Product NDC 65145-207
11-digit product format 651450207
Labeler code 65145
Product ID 65145-207_2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gatifloxacin Ophthalmic Solution 0.5%
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Caplin Steriles Limited
Application ANDA213542
Marketing category ANDA
Marketing start 2025-10-06
Substance GATIFLOXACIN ANHYDROUS
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 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 A213542-001 GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213542-001 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.
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 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC 2021-11-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213542-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2021-11-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Gatifloxacin Ophthalmic Solution 0.5%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GATIFLOXACIN ANHYDROUS 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 81485Y3A9A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992395 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 65145-207-01 Gatifloxacin Ophthalmic Solution 0.5% 1 in 1 CARTON SOLUTION 1 1 65145-207-01 Gatifloxacin Ophthalmic Solution 0.5% 2.5 mL in 1 BOTTLE SOLUTION 2.5 1
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 Units Marketing start Sample Exclude flag Status 65145-207-01 65145020701 1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE 1 bottle 2025-10-06 No No Current