OFLOXACIN

Product NDC
61919-175
11-digit product format
619190175
Labeler code
61919
Product ID
61919-175_bc784e9d-afc1-4107-a1e6-b733d00813a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OFLOXACIN
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA076407
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-175-052020-01-31C16284748780-19d75b9d0-21f4-f424-e053-dadaa90a57ceOFLOXACIN
61919-175-152020-01-31C16284748780-19d75b9d0-21f4-f424-e053-dadaa90a57ceOFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-175-05OFLOXACIN5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS53
61919-175-15OFLOXACIN15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-175-05ML - Milliliter61919-1758d05b6f5-a3aa-471c-a4f0-9cb65cfb695912015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION/ DROPS [DIRECT RX]3
WaterINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION/ DROPS [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-175OFLOXACIN SOLUTION/ DROPS [DIRECT RX]3Legacy NDC, 2 package rows20151105_bed09b0a-774b-414e-b253-a0ff5f0685a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNbed09b0a-774b-414e-b253-a0ff5f0685a03
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDbed09b0a-774b-414e-b253-a0ff5f0685a03
312075ofloxacin 0.3 % Ophthalmic SolutionSYbed09b0a-774b-414e-b253-a0ff5f0685a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61919-175-05619190175055 mL in 1 BOTTLE, DROPPER5 mlHistorical
61919-175-156191901751515 mL in 1 BOTTLE, DROPPER15 mlHistorical