FDA.reportPublic FDA data

ofloxacin

Product NDC
52959-763
11-digit product format
529590763
Labeler code
52959
Product ID
52959-763_b0521d4d-afba-41bf-a921-1dc4a277e5f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Application
ANDA078559
Marketing category
ANDA
Marketing start
2010-01-04
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-763-052019-11-13C16284748780-197449f38-b7b6-f6ea-e053-dbdaa90aa703Ofloxacin Ophthalmic Solution USP 0.3%
52959-763-102019-11-13C16284748780-197449f38-b7b6-f6ea-e053-dbdaa90aa703Ofloxacin Ophthalmic Solution USP 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-763-05ofloxacin1 in 1 CARTONSOLUTION121
52959-763-05ofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION521
52959-763-10ofloxacin10 mL in 1 BOTTLE, PLASTICSOLUTION1021
52959-763-10ofloxacin1 in 1 CARTONSOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-763-05ML - Milliliter52959-76305c6bd80-ad87-480d-9666-402eea277bc512012-07-24
52959-763-10ML - Milliliter52959-76304a1c6c5-aa3b-426c-92c6-b5e2d18ad77c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ofloxacinACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION [H.J. HARKINS COMPANY, INC.]21
ofloxacinACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION [H.J. HARKINS COMPANY, INC.]21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-763OFLOXACIN SOLUTION [H.J. HARKINS COMPANY, INC.]21Legacy NDC, 4 package rows20111229_557b44ee-bea9-4dfe-866b-f0e3d8fcd018.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN557b44ee-bea9-4dfe-866b-f0e3d8fcd01821
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD557b44ee-bea9-4dfe-866b-f0e3d8fcd01821
312075ofloxacin 0.3 % Ophthalmic SolutionSY557b44ee-bea9-4dfe-866b-f0e3d8fcd01821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-763-05529590763051 in 1 CARTONHistorical
52959-763-105295907631010 mL in 1 BOTTLE, PLASTIC10 mlHistorical