FDA.reportPublic FDA data

Ofloxacin

Product NDC
21695-881
11-digit product format
216950881
Labeler code
21695
Product ID
21695-881_75d8099b-4e08-43c0-811e-589d4fb52932
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxaxin
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Rebel Distributors Corp
Application
ANDA076616
Marketing category
ANDA
Marketing start
2008-03-17
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
21695-881-052019-09-24C16284748780-1934fe258-4c8c-48b1-e053-8cdaa90a720aOfloxacin Otic Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-881-05Ofloxacin5 mL in 1 BOTTLESOLUTION/ DROPS51
21695-881-05Ofloxacin1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-881-05ML - Milliliter21695-881bc709089-f70f-4389-ab1f-e92634c00d0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OFLOXACINACTIVE INGREDIENTA4P49JAZ9HOFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
OFLOXACINACTIVE MOIETYA4P49JAZ9HOFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0ROFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-881OFLOXACIN (OFLOXAXIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110923_75d8099b-4e08-43c0-811e-589d4fb52932.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242446ofloxacin 0.3 % Otic SolutionPSN75d8099b-4e08-43c0-811e-589d4fb529321
242446ofloxacin 3 MG/ML Otic SolutionSCD75d8099b-4e08-43c0-811e-589d4fb529321
242446ofloxacin 0.3 % Otic SolutionSY75d8099b-4e08-43c0-811e-589d4fb529321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-881-05216950881055 mL in 1 BOTTLE5 mlHistorical