Ofloxacin

Product NDC
55545-1003
11-digit product format
555451003
Labeler code
55545
Product ID
55545-1003_d2b7e684-27f1-4ee7-b235-58b632ac9694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
FDC Limited
Application
ANDA078559
Marketing category
ANDA
Marketing start
2014-12-15
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f9d82093-3de1-4841-9a42-67222d61a0cfProduct name420250515
bbed5f06-a6b7-a443-70ac-77518a9524b7Product name720250311
41679fed-052c-574b-6b40-cadcbc315b79Product name220150401

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1003-1Ofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION53
55545-1003-1Ofloxacin1 in 1 CARTONSOLUTION13
55545-1003-2Ofloxacin1 in 1 CARTONSOLUTION13
55545-1003-2Ofloxacin10 mL in 1 BOTTLE, PLASTICSOLUTION103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION [FDC LIMITED]2
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION [FDC LIMITED]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION [FDC LIMITED]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION [FDC LIMITED]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION [FDC LIMITED]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION [FDC LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1003OFLOXACIN SOLUTION [FDC LIMITED]3Legacy NDC, 4 package rows20171122_b4d09b4d-bc6a-405b-91c8-e4246336a1f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNb4d09b4d-bc6a-405b-91c8-e4246336a1f73
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDb4d09b4d-bc6a-405b-91c8-e4246336a1f73
312075ofloxacin 0.3 % Ophthalmic SolutionSYb4d09b4d-bc6a-405b-91c8-e4246336a1f73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55545-1003-1555451003015 mL in 1 BOTTLE, PLASTIC5 mlHistorical
55545-1003-2555451003021 in 1 CARTONHistorical