FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
ZYMAXID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GATIFLOXACIN5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4618BD7KJ
Rxcui992395, 992399

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

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