Ofloxacin

Product NDC
67296-2179
11-digit product format
672962179
Labeler code
67296
Product ID
67296-2179_44f66b04-9be9-1920-e063-6294a90a2b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Redpharm Drug
Application
ANDA216328
Marketing category
ANDA
Marketing start
2024-10-31
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OFLOXACIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA4P49JAZ9H
Rxcui242446

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
67296-2179-5Ofloxacin1 in 1 CARTONSOLUTION/ DROPS12
67296-2179-5Ofloxacin5 mL in 1 BOTTLESOLUTION/ DROPS52

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSN3dd035d0-c3ec-3fc2-e063-6294a90a4aac2
242446ofloxacin 3 MG/ML Otic SolutionSCD3dd035d0-c3ec-3fc2-e063-6294a90a4aac2
242446ofloxacin 0.3 % Otic SolutionSY3dd035d0-c3ec-3fc2-e063-6294a90a4aac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2179-5672962179051 BOTTLE in 1 CARTON (67296-2179-5) / 5 mL in 1 BOTTLE1 bottle2024-10-31NoNoHistorical