ofloxacin

Product NDC
68071-2894
11-digit product format
680712894
Labeler code
68071
Product ID
68071-2894_ef17b4bf-f210-4a6d-e053-2a95a90ae494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin otic
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA216130
Marketing category
ANDA
Marketing start
2022-07-15
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
2023-12-31
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
68071-2894-52025-01-30C16284748780-12cef2736-b4b4-d83d-e063-dadaa90ab31fOfloxacin Otic Solution 0.3% (Sterile) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2894-5ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2894OFLOXACIN (OFLOXACIN OTIC) SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221206_ef17b4bf-f20f-4a6d-e053-2a95a90ae494.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSNef17b4bf-f20f-4a6d-e053-2a95a90ae4941
242446ofloxacin 3 MG/ML Otic SolutionSCDef17b4bf-f20f-4a6d-e053-2a95a90ae4941
242446ofloxacin 0.3 % Otic SolutionSYef17b4bf-f20f-4a6d-e053-2a95a90ae4941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2894-5680712894055 mL in 1 BOTTLE, DROPPER (68071-2894-5) 5 ml2022-12-050000-00-00NoNoCurrent