Ofloxacin

Product NDC
68071-2544
11-digit product format
680712544
Labeler code
68071
Product ID
68071-2544_cd019419-dbf0-2145-e053-2a95a90a3935
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticaals,Inc.
Application
ANDA076513
Marketing category
ANDA
Marketing start
2019-03-01
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
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2544-5Ofloxacin1 in 1 CARTONSOLUTION12
68071-2544-5Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2544OFLOXACIN SOLUTION [NUCARE PHARMACEUTICAALS,INC.]2Legacy NDC, 2 package rows20230718_cd01954d-918b-456a-e053-2995a90a859c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNcd01954d-918b-456a-e053-2995a90a859c2
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDcd01954d-918b-456a-e053-2995a90a859c2
312075ofloxacin 0.3 % Ophthalmic SolutionSYcd01954d-918b-456a-e053-2995a90a859c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2544-5680712544051 BOTTLE, DROPPER in 1 CARTON (68071-2544-5) > 5 mL in 1 BOTTLE, DROPPER2021-09-270000-00-00NoNoCurrent