Home NDC 0023-3615 ZYMAXID
Product NDC 0023-3615
11-digit product format 000233615
Labeler code 0023
Product ID 0023-3615_8ecbdc67-bc68-4437-b99d-9924e25dfe67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gatifloxacin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Allergan, Inc.
Application NDA022548
Marketing category NDA
Marketing start 2010-05-19
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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022548-001 ZYMAXID 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2010-05-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ZYMAXID
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992395 Internal RxNorm lookup 992399 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 0023-3615-01 ZYMAXID 1 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 1 11 0023-3615-01 ZYMAXID 1 in 1 CARTON SOLUTION/ DROPS 1 11 0023-3615-25 ZYMAXID 1 in 1 CARTON SOLUTION/ DROPS 1 11 0023-3615-25 ZYMAXID 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded gatifloxacin ACTIVE INGREDIENT L4618BD7KJ ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 4 gatifloxacin anhydrous ACTIVE MOIETY 81485Y3A9A ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 4 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 4 edetate disodium INACTIVE INGREDIENT 7FLD91C86K ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 4 hydrochloric acid INACTIVE INGREDIENT QTT17582CB ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 4 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 4 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 4 gatifloxacin ACTIVE INGREDIENT L4618BD7KJ ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 gatifloxacin ACTIVE MOIETY L4618BD7KJ ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 hydrochloric acid INACTIVE INGREDIENT QTT17582CB ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-3615 ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20241122_1160b16c-929a-4e85-9c0b-1d8c96a7678b.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 0023-3615-01 00023361501 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) / 1 mL in 1 BOTTLE, DROPPER 2010-05-19 0000-00-00 Yes No Current 0023-3615-25 00023361525 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) / 2.5 mL in 1 BOTTLE, DROPPER 2010-05-19 0000-00-00 No No Current