Ofloxacin Ophth Soln

Product NDC
72189-472
11-digit product format
721890472
Labeler code
72189
Product ID
72189-472_4d3a583a-dad5-8766-e063-6394a90a525f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin Ophth Soln
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Direct_Rx
Application
ANDA215886
Marketing category
ANDA
Marketing start
2023-05-22
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ofloxacin Ophth Soln
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OFLOXACIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA4P49JAZ9H
Rxcui312075

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
72189-472-05Ofloxacin Ophth Soln5 mL in 1 CARTONSOLUTION/ DROPS53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-472-05ML - Milliliter72189-4725f7324fe-6d95-4fae-a56b-c936460fbe3412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-472OFLOXACIN OPHTH SOLN SOLUTION/ DROPS [DIRECT_RX]2Current NDC, 1 package rows20250123_fc4d4b14-1eeb-0fba-e053-6394a90a738e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNfc4d4b14-1eeb-0fba-e053-6394a90a738e3
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDfc4d4b14-1eeb-0fba-e053-6394a90a738e3
312075ofloxacin 0.3 % Ophthalmic SolutionSYfc4d4b14-1eeb-0fba-e053-6394a90a738e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-472-05721890472055 mL in 1 CARTON (72189-472-05) 5 ml2023-05-22NoNoCurrent