Ofloxacin

Product NDC
13985-602
11-digit product format
139850602
Labeler code
13985
Product ID
13985-602_51308ecf-1ef6-495b-954f-455acd51501a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
MWI
Application
ANDA076407
Marketing category
ANDA
Marketing start
2015-03-27
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
2023-12-31
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
13985-602-052024-01-30C16284748780-11030e365-6986-111a-e063-dadaa90a10e2fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4
13985-602-102024-01-30C16284748780-11030e365-6986-111a-e063-dadaa90a10e2fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-602-05Ofloxacin1 in 1 CARTONSOLUTION/ DROPS16
13985-602-05Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS56
13985-602-10Ofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS106
13985-602-10Ofloxacin1 in 1 CARTONSOLUTION/ DROPS16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OfloxacinACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [MWI]1
OfloxacinACTIVE MOIETYA4P49JAZ9HOFLOXACIN SOLUTION/ DROPS [MWI]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN SOLUTION/ DROPS [MWI]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBOFLOXACIN SOLUTION/ DROPS [MWI]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XOFLOXACIN SOLUTION/ DROPS [MWI]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IOFLOXACIN SOLUTION/ DROPS [MWI]1
WaterINACTIVE INGREDIENT059QF0KO0ROFLOXACIN SOLUTION/ DROPS [MWI]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-602OFLOXACIN SOLUTION/ DROPS [MWI]6Legacy NDC, 4 package rows20220204_fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNfcd7c5d7-42f4-4dcb-bc84-d976fafd5df46
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDfcd7c5d7-42f4-4dcb-bc84-d976fafd5df46
312075ofloxacin 0.3 % Ophthalmic SolutionSYfcd7c5d7-42f4-4dcb-bc84-d976fafd5df46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13985-602-05139850602051 BOTTLE, DROPPER in 1 CARTON (13985-602-05) > 5 mL in 1 BOTTLE, DROPPER2015-03-270000-00-00NoNoCurrent
13985-602-10139850602101 BOTTLE, DROPPER in 1 CARTON (13985-602-10) > 10 mL in 1 BOTTLE, DROPPER2015-03-270000-00-00NoNoCurrent