Ofloxacin

Product NDC
68071-2265
11-digit product format
680712265
Labeler code
68071
Product ID
68071-2265_1d76541f-80dc-2a55-e063-6294a90aa5f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076622
Marketing category
ANDA
Marketing start
2004-05-14
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
68071-2265-1Ofloxacin1 in 1 CARTONSOLUTION/ DROPS13
68071-2265-1Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2265OFLOXACIN SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240719_af861f20-5ec8-2883-e053-2a95a90a2312.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSNaf861f20-5ec8-2883-e053-2a95a90a23123
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCDaf861f20-5ec8-2883-e053-2a95a90a23123
312075ofloxacin 0.3 % Ophthalmic SolutionSYaf861f20-5ec8-2883-e053-2a95a90a23123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2265-1680712265011 BOTTLE, DROPPER in 1 CARTON (68071-2265-1) / 5 mL in 1 BOTTLE, DROPPER2020-09-170000-00-00NoNoCurrent