NDC 68788-9504

Ofloxacin Otic

Ofloxacin

Ofloxacin Otic is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Ofloxacin.

• Product ID: 68788-9504_715b4f79-3294-46f5-bc96-22f85dc47da2
• NDC: 68788-9504
• Product Type: Human Prescription Drug
• Proprietary Name: Ofloxacin Otic
• Generic Name: Ofloxacin
• Dosage Form: Solution
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 2014-02-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076527
• Labeler Name: Preferred Pharmaceuticals, Inc.
• Substance Name: OFLOXACIN
• Active Ingredient Strength: 3 mg/mL
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68788-9504-5

5 mL in 1 BOTTLE, DROPPER (68788-9504-5)

• Marketing Start Date: 2014-02-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-9504-5 [68788950405]

Ofloxacin Otic SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA076527
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-02-21
• Marketing End Date: 2019-11-07

Drug Details

Active Ingredients

Ingredient	Strength
OFLOXACIN	3 mg/mL

OpenFDA Data

• SPL SET ID: 7397f901-7ce5-4751-a996-22d51d95a888
• Manufacturer:
  • Preferred Pharmaceuticals, Inc.
• UNII:
  • A4P49JAZ9H
• RxNorm Concept Unique ID - RxCUI:
  • 242446

Pharmacological Class

• Quinolone Antimicrobial [EPC]
• Quinolones [CS]

NDC Crossover Matching brand name "Ofloxacin Otic" or generic name "Ofloxacin"

NDC	Brand Name	Generic Name
50090-1090	Ofloxacin Otic	Ofloxacin
68071-1588	Ofloxacin Otic	Ofloxacin Otic
68071-1630	Ofloxacin Otic	Ofloxacin Otic
68788-9504	Ofloxacin Otic	Ofloxacin Otic
53002-2604	Ofloxacin Otic	Ofloxacin Otic
60505-0363	Ofloxacin Otic	Ofloxacin Otic
63187-184	Ofloxacin Otic	Ofloxacin Otic
72189-108	OFLOXACIN OTIC	OFLOXACIN OTIC
11980-779	OCUFLOX	ofloxacin
0404-7189	Ofloxacin	Ofloxacin
0517-0760	Ofloxacin	Ofloxacin
13985-602	Ofloxacin	Ofloxacin
17478-713	Ofloxacin	Ofloxacin
21695-439	Ofloxacin	Ofloxacin
24208-410	Ofloxacin	Ofloxacin
24208-434	Ofloxacin	Ofloxacin
33261-737	Ofloxacin	Ofloxacin
40042-049	Ofloxacin	Ofloxacin
42254-257	Ofloxacin	Ofloxacin
50090-0891	Ofloxacin	Ofloxacin
50090-1346	Ofloxacin	Ofloxacin
50090-1736	Ofloxacin	Ofloxacin
50090-5186	Ofloxacin	ofloxacin
50090-5209	Ofloxacin	ofloxacin
50090-5210	Ofloxacin	ofloxacin
50090-5425	Ofloxacin	Ofloxacin
50090-5670	Ofloxacin	Ofloxacin Otic
50383-024	Ofloxacin	Ofloxacin