Ofloxacin - 50383-025-10 - (Ofloxaxin)

Alphabetical Index


Drug Information of Ofloxacin

Product NDC: 50383-025
Proprietary Name: Ofloxacin
Non Proprietary Name: Ofloxaxin
Active Ingredient(s): 3    mg/mL & nbsp;   Ofloxaxin
Administration Route(s): AURICULAR (OTIC)
Dosage Form(s): SOLUTION/ DROPS
Coding System: National Drug Codes(NDC)

Labeler Information of Ofloxacin

Product NDC: 50383-025
Labeler Name: Hi-Tech Pharmacal Co., Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076616
Marketing Category: ANDA
Start Marketing Date: 20080317

Package Information of Ofloxacin

Package NDC: 50383-025-10
Package Description: 1 BOTTLE in 1 CARTON (50383-025-10) > 10 mL in 1 BOTTLE

NDC Information of Ofloxacin

NDC Code 50383-025-10
Proprietary Name Ofloxacin
Package Description 1 BOTTLE in 1 CARTON (50383-025-10) > 10 mL in 1 BOTTLE
Product NDC 50383-025
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Ofloxaxin
Dosage Form Name SOLUTION/ DROPS
Route Name AURICULAR (OTIC)
Start Marketing Date 20080317
Marketing Category Name ANDA
Labeler Name Hi-Tech Pharmacal Co., Inc.
Substance Name OFLOXACIN
Strength Number 3
Strength Unit mg/mL
Pharmaceutical Classes Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]

Complete Information of Ofloxacin


General Information