NDC 0409-1207

Gentamicin Sulfate

Gentamicin Sulfate

Gentamicin Sulfate is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Gentamicin Sulfate.

• Product ID: 0409-1207_54038252-b0e3-4f67-9473-22725fd055f8
• NDC: 0409-1207
• Product Type: Human Prescription Drug
• Proprietary Name: Gentamicin Sulfate
• Generic Name: Gentamicin Sulfate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2005-08-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA062420
• Labeler Name: Hospira, Inc.
• Substance Name: GENTAMICIN SULFATE
• Active Ingredient Strength: 40 mg/mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0409-1207-03

25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-03) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-13)

• Marketing Start Date: 2005-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-1207-25 [00409120725]

Gentamicin Sulfate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062420
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-12-09

NDC 0409-1207-03 [00409120703]

Gentamicin Sulfate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062420
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-08-29

NDC 0409-1207-13 [00409120713]

Gentamicin Sulfate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062420
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-10-24

NDC 0409-1207-15 [00409120715]

Gentamicin Sulfate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062420
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-03

Drug Details

Active Ingredients

Ingredient	Strength
GENTAMICIN SULFATE	40 mg/mL

OpenFDA Data

• SPL SET ID: 977180b3-a222-4282-d485-4a3217674305
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 8X7386QRLV
• RxNorm Concept Unique ID - RxCUI:
  • 1870650

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