NDC 0168-0078

Gentamicin sulfate

Gentamicin Sulfate

Gentamicin sulfate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Gentamicin.

• Product ID: 0168-0078_c6dd33a2-904b-4015-8477-5018db198fdc
• NDC: 0168-0078
• Product Type: Human Prescription Drug
• Proprietary Name: Gentamicin sulfate
• Generic Name: Gentamicin Sulfate
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-03-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA062533
• Labeler Name: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• Substance Name: GENTAMICIN
• Active Ingredient Strength: 1 mg/g
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0168-0078-15

15 g in 1 TUBE (0168-0078-15)

• Marketing Start Date: 2010-03-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0078-15 [00168007815]

Gentamicin sulfate OINTMENT

• Marketing Category: ANDA
• Application Number: ANDA062533
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-03-17
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GENTAMICIN	1 mg/g

OpenFDA Data

• SPL SET ID: f986fa2a-e667-452f-be4c-bad8588af525
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • T6Z9V48IKG
• RxNorm Concept Unique ID - RxCUI:
  • 310465

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]

NDC Crossover Matching brand name "Gentamicin sulfate" or generic name "Gentamicin Sulfate"

NDC	Brand Name	Generic Name
0168-0071	Gentamicin Sulfate	gentamicin sulfate
0168-0078	Gentamicin sulfate	Gentamicin Sulfate
0404-9865	Gentamicin Sulfate	Gentamicin Sulfate
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE
0713-0682	Gentamicin Sulfate	Gentamicin Sulfate
0713-0683	Gentamicin Sulfate	Gentamicin Sulfate
13985-603	Gentamicin Sulfate	Gentamicin Sulfate
17478-283	Gentamicin Sulfate	Gentamicin Sulfate
68071-4827	GENTAMICIN SULFATE	GENTAMICIN SULFATE
68071-4775	Gentamicin Sulfate	Gentamicin Sulfate
68788-0633	Gentamicin Sulfate	Gentamicin Sulfate
68788-6342	Gentamicin Sulfate	Gentamicin Sulfate
68788-7336	Gentamicin Sulfate	Gentamicin Sulfate
68788-9921	GENTAMICIN SULFATE	GENTAMICIN SULFATE
70518-1323	Gentamicin Sulfate	Gentamicin Sulfate
17478-826	Gentamicin Sulfate	Gentamicin Sulfate
21695-187	GENTAMICIN SULFATE	GENTAMICIN SULFATE
33261-604	GENTAMICIN SULFATE	GENTAMICIN SULFATE
35356-707	GENTAMICIN SULFATE	GENTAMICIN SULFATE
45865-672	Gentamicin Sulfate	Gentamicin Sulfate
45802-046	Gentamicin Sulfate	Gentamicin Sulfate
45802-056	Gentamicin Sulfate	Gentamicin Sulfate
50090-0249	Gentamicin Sulfate	Gentamicin Sulfate
50090-0568	Gentamicin Sulfate	Gentamicin Sulfate
50090-0569	Gentamicin Sulfate	Gentamicin Sulfate
50090-1883	Gentamicin Sulfate	Gentamicin Sulfate
50436-6752	Gentamicin Sulfate	Gentamicin Sulfate
50436-6754	Gentamicin Sulfate	Gentamicin Sulfate
52584-207	Gentamicin Sulfate	Gentamicin Sulfate
52565-090	Gentamicin Sulfate	Gentamicin Sulfate
53217-229	Gentamicin Sulfate	Gentamicin Sulfate
52959-103	GENTAMICIN SULFATE	GENTAMICIN SULFATE
53002-9290	Gentamicin Sulfate	Gentamicin Sulfate
55045-1147	Gentamicin Sulfate	Gentamicin Sulfate
55154-2392	Gentamicin Sulfate	Gentamicin Sulfate
60758-188	GENTAMICIN SULFATE	GENTAMICIN SULFATE
61314-633	Gentamicin Sulfate	Gentamicin Sulfate
61919-106	gentamicin sulfate	gentamicin sulfate
61919-918	Gentamicin Sulfate	Gentamicin Sulfate
63187-163	GENTAMICIN SULFATE	GENTAMICIN SULFATE
63187-764	Gentamicin Sulfate	Gentamicin Sulfate
63187-560	Gentamicin Sulfate	Gentamicin Sulfate
66267-971	Gentamicin Sulfate	Gentamicin Sulfate
24208-580	Gentamicin Sulfate	Gentamicin Sulfate
52565-085	Gentamicin Sulfate	Gentamicin Sulfate
0404-9866	Gentamicin	Gentamicin Sulfate
0338-0503	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate
0338-0505	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate
0338-0507	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate
0338-0509	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate