NDC 75834-119

OFLOXACIN

Ofloxacin

OFLOXACIN is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is Ofloxacin.

• Product ID: 75834-119_4662b8b1-2cfe-4472-bd5b-374737254a4f
• NDC: 75834-119
• Product Type: Human Prescription Drug
• Proprietary Name: OFLOXACIN
• Generic Name: Ofloxacin
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091656
• Labeler Name: Nivagen Pharmaceuticals, Inc.
• Substance Name: OFLOXACIN
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 75834-119-01

100 TABLET, COATED in 1 BOTTLE (75834-119-01)

• Marketing Start Date: 2016-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75834-119-50 [75834011950]

OFLOXACIN TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA091656
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-15
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-06

NDC 75834-119-01 [75834011901]

OFLOXACIN TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA091656
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-15
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-06

NDC 75834-119-05 [75834011905]

OFLOXACIN TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA091656
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-15
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-06

Drug Details

Active Ingredients

Ingredient	Strength
OFLOXACIN	300 mg/1

OpenFDA Data

• SPL SET ID: ee1bf431-97fa-4aba-9cc3-0cfcea779ca2
• Manufacturer:
  • Nivagen Pharmaceuticals, Inc.
• UNII:
  • A4P49JAZ9H
• RxNorm Concept Unique ID - RxCUI:
  • 198048
  • 198049
  • 198050
• UPC Code:
  • 0375834120508
  • 0375834119502
  • 0375834112503

Pharmacological Class

• Quinolone Antimicrobial [EPC]
• Quinolones [CS]

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

NDC	Brand Name	Generic Name
0404-7189	Ofloxacin	Ofloxacin
0517-0760	Ofloxacin	Ofloxacin
13985-602	Ofloxacin	Ofloxacin
17478-713	Ofloxacin	Ofloxacin
21695-439	Ofloxacin	Ofloxacin
21695-881	Ofloxacin	Ofloxaxin
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
50090-3836	Ofloxacin	Ofloxaxin
50090-5186	Ofloxacin	ofloxacin
50090-5209	Ofloxacin	ofloxacin
50090-5210	Ofloxacin	ofloxacin
50090-5425	Ofloxacin	Ofloxacin
68047-713	ofloxacin	ofloxacin
68071-1607	Ofloxacin	Ofloxacin
68071-4055	Ofloxacin	Ofloxacin
68387-106	Ofloxacin	Ofloxacin
68788-0617	Ofloxacin	Ofloxacin
68788-8993	Ofloxacin	Ofloxacin
68788-7003	Ofloxacin	Ofloxacin
68788-9204	Ofloxacin	Ofloxacin
70518-0308	Ofloxacin	Ofloxacin
70518-0192	Ofloxacin	Ofloxacin
70518-1892	Ofloxacin	Ofloxacin
71209-099	OFLOXACIN	OFLOXACIN
71209-098	OFLOXACIN	OFLOXACIN
71209-097	OFLOXACIN	OFLOXACIN
75834-119	OFLOXACIN	OFLOXACIN
75834-112	OFLOXACIN	OFLOXACIN
75834-200	OFLOXACIN	OFLOXACIN
75834-201	OFLOXACIN	OFLOXACIN
75834-120	OFLOXACIN	OFLOXACIN
75834-199	OFLOXACIN	OFLOXACIN
50383-024	Ofloxacin	Ofloxacin
50436-0713	Ofloxacin	Ofloxacin
50383-025	Ofloxacin	Ofloxacin
50436-6112	Ofloxacin	Ofloxacin
52959-763	ofloxacin	ofloxacin
53002-1324	Ofloxacin	Ofloxacin
53002-1604	Ofloxacin	Ofloxacin
55111-162	Ofloxacin	Ofloxacin
55111-161	Ofloxacin	Ofloxacin
55111-160	Ofloxacin	Ofloxacin
55700-066	Ofloxacin	Ofloxacin