Ofloxacin

Product NDC
50090-5186
11-digit product format
500905186
Labeler code
50090
Product ID
50090-5186_370ae18e-5219-4098-a0d3-4683cf159659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA076513
Marketing category
ANDA
Marketing start
2019-03-01
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
50090-5186-0Ofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION109
50090-5186-0Ofloxacin1 in 1 CARTONSOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5186-0ML - Milliliter50090-518686e1fa3f-cece-4f62-93b4-3db4458373e412022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5186OFLOXACIN SOLUTION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20240426_392d458f-8815-49f4-9c2b-0e721e295b1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN392d458f-8815-49f4-9c2b-0e721e295b1f9
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD392d458f-8815-49f4-9c2b-0e721e295b1f9
312075ofloxacin 0.3 % Ophthalmic SolutionSY392d458f-8815-49f4-9c2b-0e721e295b1f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5186-0500905186001 BOTTLE, DROPPER in 1 CARTON (50090-5186-0) / 10 mL in 1 BOTTLE, DROPPER2020-09-290000-00-00NoNoCurrent