Ofloxacin

Product NDC
60760-970
11-digit product format
607600970
Labeler code
60760
Product ID
60760-970_27c26e00-7805-ea5d-e063-6394a90a2b10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078559
Marketing category
ANDA
Marketing start
2014-12-15
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
60760-970-05Ofloxacin1 in 1 CARTONSOLUTION11
60760-970-05Ofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-970-05ML - Milliliter60760-97069cf63d5-ef70-484c-ae4d-0514a50178a612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-970OFLOXACIN SOLUTION [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 2 package rows20241206_27c247e5-ef93-e9a5-e063-6394a90a2e1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN27c247e5-ef93-e9a5-e063-6394a90a2e1e1
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD27c247e5-ef93-e9a5-e063-6394a90a2e1e1
312075ofloxacin 0.3 % Ophthalmic SolutionSY27c247e5-ef93-e9a5-e063-6394a90a2e1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-970-05607600970051 BOTTLE, PLASTIC in 1 CARTON (60760-970-05) / 5 mL in 1 BOTTLE, PLASTIC2024-11-22NoNoCurrent