Ofloxacin

Product NDC
71205-420
11-digit product format
712050420
Labeler code
71205
Product ID
71205-420_e65f9309-c5da-4159-ba09-28754fe12593
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA076513
Marketing category
ANDA
Marketing start
2019-03-01
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
71205-420-05Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION52
71205-420-05Ofloxacin1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-420OFLOXACIN SOLUTION [PROFICIENT RX LP]2Current NDC, Legacy NDC, 2 package rows20240822_5a9de529-6f85-467a-97b0-8ce124c31173.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312075ofloxacin 0.3 % Ophthalmic SolutionPSN5a9de529-6f85-467a-97b0-8ce124c311732
312075ofloxacin 3 MG/ML Ophthalmic SolutionSCD5a9de529-6f85-467a-97b0-8ce124c311732
312075ofloxacin 0.3 % Ophthalmic SolutionSY5a9de529-6f85-467a-97b0-8ce124c311732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-420-05712050420051 BOTTLE, DROPPER in 1 CARTON (71205-420-05) / 5 mL in 1 BOTTLE, DROPPER2020-03-010000-00-00NoNoCurrent