Ofloxacin

Product NDC
50090-5210
11-digit product format
500905210
Labeler code
50090
Product ID
50090-5210_272ad015-e45a-470e-b04f-b4b8dc8f89d1
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
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5210-02023-01-30C16284748780-1f386c649-bb7f-0266-e053-dadaa90a7c1aPRESCRIBING INFORMATION Rx Only Ofloxacin Ophthalmic Solution, USP 0.3% STERILE OPHTHALMIC SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5210-0Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION51
50090-5210-0Ofloxacin1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5210OFLOXACIN SOLUTION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20210602_4a86ae0b-c644-4cef-9ecf-07ec31590af5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN4a86ae0b-c644-4cef-9ecf-07ec31590af51
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD4a86ae0b-c644-4cef-9ecf-07ec31590af51
312075ofloxacin 0.3 % Ophthalmic SolutionSY4a86ae0b-c644-4cef-9ecf-07ec31590af51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5210-0500905210001 BOTTLE, DROPPER in 1 CARTON (50090-5210-0) > 5 mL in 1 BOTTLE, DROPPER2020-10-050000-00-00NoNoCurrent