Home NDC 61314-672 Gatifloxacin
Product NDC 61314-672
11-digit product format 613140672
Labeler code 61314
Product ID 61314-672_20dfbbfa-5c67-4ac4-a90a-a7dd29395e71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gatifloxacin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Sandoz Inc
Application ANDA204227
Marketing category ANDA
Marketing start 2016-10-03
Substance GATIFLOXACIN
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 A204227-001 GATIFLOXACIN GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204227-001 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 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204227-001 GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2016-07-11 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 Gatifloxacin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GATIFLOXACIN 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L4618BD7KJ 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 61314-672-25 Gatifloxacin 1 in 1 CARTON SOLUTION/ DROPS 1 14 61314-672-25 Gatifloxacin 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61314-672 GATIFLOXACIN SOLUTION/ DROPS [SANDOZ INC] 14 Current NDC, Legacy NDC, 2 package rows 20220218_9e6fcd14-1fee-493f-811c-e18cbfbee65b.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 Marketing start Marketing end Sample Exclude flag Status 61314-672-25 61314067225 1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 2.5 mL in 1 BOTTLE, DROPPER 2016-10-03 0000-00-00 No No Current