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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022548-001ZYMAXIDGATIFLOXACIN0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N022548-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022548-001ZYMAXID0.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2010-05-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022548-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022548-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022548-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022548-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022548-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022548-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022548-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022548-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022548-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022548-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022548-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022548-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022548-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022548-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022548-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022548-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022548-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022548-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022548-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022548-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022548-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N022548-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022548-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022548-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022548-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N022548-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022548-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022548-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022548-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022548-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022548-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022548-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022548-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022548-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022548-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022548-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022548-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022548-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022548-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022548-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
ZYMAXID
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GATIFLOXACIN5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L4618BD7KJInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1160b16c-929a-4e85-9c0b-1d8c96a7678bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
239a4851-e06b-598d-a52e-afd530b4338cProduct name520220524
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
5f7f16b4-647e-0c57-05de-15573d3a6485Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-3615-01ZYMAXID1 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS111
0023-3615-01ZYMAXID1 in 1 CARTONSOLUTION/ DROPS111
0023-3615-25ZYMAXID1 in 1 CARTONSOLUTION/ DROPS111
0023-3615-25ZYMAXID2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3615-25ML - Milliliter0023-3615251b6de4-ffb3-4f38-a62c-f0820850fab612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gatifloxacinACTIVE INGREDIENTL4618BD7KJZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]4
gatifloxacin anhydrousACTIVE MOIETY81485Y3A9AZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]4
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]4
edetate disodiumINACTIVE INGREDIENT7FLD91C86KZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]4
hydrochloric acidINACTIVE INGREDIENTQTT17582CBZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]4
sodium chlorideINACTIVE INGREDIENT451W47IQ8XZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]4
gatifloxacinACTIVE INGREDIENTL4618BD7KJZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
gatifloxacinACTIVE MOIETYL4618BD7KJZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3615ZYMAXID (GATIFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.]11Current NDC, Legacy NDC, 4 package rows20241122_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYMAXIDGATIFLOXACINAllergan, Inc.1160b16c-929a-4e85-9c0b-1d8c96a7678b2016-09-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 022548
application number: NDA022548
ndc (product): 0023-3615

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992395gatifloxacin 0.5 % Ophthalmic SolutionPSN1160b16c-929a-4e85-9c0b-1d8c96a7678b11
992399ZYMAXID 0.5 % Ophthalmic SolutionPSN1160b16c-929a-4e85-9c0b-1d8c96a7678b11
992399gatifloxacin 5 MG/ML Ophthalmic Solution [Zymaxid]SBD1160b16c-929a-4e85-9c0b-1d8c96a7678b11
992395gatifloxacin 5 MG/ML Ophthalmic SolutionSCD1160b16c-929a-4e85-9c0b-1d8c96a7678b11
992395gatifloxacin 0.5 % Ophthalmic SolutionSY1160b16c-929a-4e85-9c0b-1d8c96a7678b11
992399Zymaxid 0.5 % Ophthalmic SolutionSY1160b16c-929a-4e85-9c0b-1d8c96a7678b11
992399Zymaxid 5 MG/ML Ophthalmic SolutionSY1160b16c-929a-4e85-9c0b-1d8c96a7678b11
992395gatifloxacin 0.5 % Ophthalmic SolutionPSN218fba79-c773-482d-90aa-7cf678694c362
992399ZYMAXID 0.5 % Ophthalmic SolutionPSN218fba79-c773-482d-90aa-7cf678694c362
992399gatifloxacin 5 MG/ML Ophthalmic Solution [Zymaxid]SBD218fba79-c773-482d-90aa-7cf678694c362
992395gatifloxacin 5 MG/ML Ophthalmic SolutionSCD218fba79-c773-482d-90aa-7cf678694c362
992395gatifloxacin 0.5 % Ophthalmic SolutionSY218fba79-c773-482d-90aa-7cf678694c362
992399Zymaxid 0.5 % Ophthalmic SolutionSY218fba79-c773-482d-90aa-7cf678694c362
992399Zymaxid 5 MG/ML Ophthalmic SolutionSY218fba79-c773-482d-90aa-7cf678694c362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-3615-01000233615011 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) / 1 mL in 1 BOTTLE, DROPPER2010-05-190000-00-00YesNoCurrent
0023-3615-25000233615251 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) / 2.5 mL in 1 BOTTLE, DROPPER2010-05-190000-00-00NoNoCurrent