Ofloxacin Otic

Product NDC
72162-1709
11-digit product format
721621709
Labeler code
72162
Product ID
72162-1709_7cd6a4b8-fd7f-4d2e-b20b-9d7d1109b69b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Bryant Ranch Prepack
Application
ANDA076527
Marketing category
ANDA
Marketing start
2004-05-14
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 Otic
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
72162-1709-2Ofloxacin Otic5 mL in 1 BOTTLE, DROPPERSOLUTION5100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1709-2ML - Milliliter72162-17095897f7fc-4caa-4824-a7b1-7ecb078c97d512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1709OFLOXACIN OTIC (OFLOXACIN) SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240922_4f4048b2-3ae8-441a-b1e3-7311fac00f94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSN4f4048b2-3ae8-441a-b1e3-7311fac00f94100
242446ofloxacin 3 MG/ML Otic SolutionSCD4f4048b2-3ae8-441a-b1e3-7311fac00f94100
242446ofloxacin 0.3 % Otic SolutionSY4f4048b2-3ae8-441a-b1e3-7311fac00f94100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1709-2721621709025 mL in 1 BOTTLE, DROPPER (72162-1709-2) 5 ml2024-09-20NoNoHistorical