Home NDC 60758-615 gatifloxacin
Product NDC 60758-615
11-digit product format 607580615
Labeler code 60758
Product ID 60758-615_a784d48b-b36a-4960-81b6-b1de036d65e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gatifloxacin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Pacific Pharma, Inc.
Application NDA022548
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-04-15
Marketing end 0000-00-00
Substance GATIFLOXACIN
Active strength 5 mg/mL
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 N022548-001 ZYMAXID GATIFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022548-001 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 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60758-615 GATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 7 Legacy NDC 20241201_3dd6ac6b-877a-46c7-bbc8-c7119f341abe.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZYMAXID GATIFLOXACIN Allergan, Inc. 1160b16c-929a-4e85-9c0b-1d8c96a7678b 2016-09-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 022548 application number: NDA022548
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60758-615-25 60758061525 1 BOTTLE, DROPPER in 1 CARTON (60758-615-25) > 2.5 mL in 1 BOTTLE, DROPPER 2015-04-15 0000-00-00 No No Current