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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60758-615-25ML - Milliliter60758-615a1511d1d-d2b6-4c74-91d7-a18776712eaf12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gatifloxacinACTIVE INGREDIENTL4618BD7KJGATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA]1
gatifloxacin anhydrousACTIVE MOIETY81485Y3A9AGATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7GATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KGATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBGATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XGATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IGATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA]1
waterINACTIVE INGREDIENT059QF0KO0RGATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60758-615GATIFLOXACIN SOLUTION/ DROPS [PACIFIC PHARMA, INC.]7Legacy NDC20241201_3dd6ac6b-877a-46c7-bbc8-c7119f341abe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60758-615-25607580615251 BOTTLE, DROPPER in 1 CARTON (60758-615-25) > 2.5 mL in 1 BOTTLE, DROPPER2015-04-150000-00-00NoNoCurrent