Ofloxacin

Product NDC
50090-1744
11-digit product format
500901744
Labeler code
50090
Product ID
50090-1744_2c2b3d4c-0427-4618-8edd-435118c185bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA076622
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
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
50090-1744-0Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS55
50090-1744-0Ofloxacin1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1744-0ML - Milliliter50090-1744fa90d7c1-ce56-446d-a6a5-d2807508784512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1744OFLOXACIN SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]5Current NDC, 2 package rows20230815_ff88214e-19b5-428d-a10d-91c3edc89a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNff88214e-19b5-428d-a10d-91c3edc89a665
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDff88214e-19b5-428d-a10d-91c3edc89a665
312075ofloxacin 0.3 % Ophthalmic SolutionSYff88214e-19b5-428d-a10d-91c3edc89a665

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1744-0500901744001 BOTTLE, DROPPER in 1 CARTON (50090-1744-0) / 5 mL in 1 BOTTLE, DROPPER2015-03-17NoNoCurrent