Ofloxacin ophthalmic

Product NDC
59390-140
11-digit product format
593900140
Labeler code
59390
Product ID
59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Altaire Pharmaceuticals Inc.
Application
ANDA202692
Marketing category
ANDA
Marketing start
2013-05-31
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 ophthalmic
Listing expiration
2026-12-31

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
59390-140-05Ofloxacin ophthalmic5 mL in 1 BOTTLE, DROPPERSOLUTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59390-140-05ML - Milliliter59390-140e8a8e857-9d8a-40c4-a463-87a8e79d857d12014-08-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59390-140OFLOXACIN OPHTHALMIC (OFLOXACIN) SOLUTION [ALTAIRE PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 1 package rows20221101_fe564e33-8f5d-4b57-87a9-7afae02eaf97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNfe564e33-8f5d-4b57-87a9-7afae02eaf976
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDfe564e33-8f5d-4b57-87a9-7afae02eaf976
312075ofloxacin 0.3 % Ophthalmic SolutionSYfe564e33-8f5d-4b57-87a9-7afae02eaf976

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59390-140-05593900140055 mL in 1 BOTTLE, DROPPER (59390-140-05) 5 ml2013-05-310000-00-00NoNoCurrent