NDC 0703-9040

Amikacin Sulfate

Amikacin Sulfate

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

• Product ID: 0703-9040_149ae350-d46a-456b-a589-2cd758556e84
• NDC: 0703-9040
• Product Type: Human Prescription Drug
• Proprietary Name: Amikacin Sulfate
• Generic Name: Amikacin Sulfate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 1993-10-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA064045
• Labeler Name: Teva Parenteral Medicines, Inc.
• Substance Name: AMIKACIN SULFATE
• Active Ingredient Strength: 1 g/4mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0703-9040-03

10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9040-03) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-9040-01)

• Marketing Start Date: 1993-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0703-9040-91 [00703904091]

Amikacin Sulfate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064045
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-11-14
• Marketing End Date: 2016-09-30

NDC 0703-9040-03 [00703904003]

Amikacin Sulfate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064045
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1993-10-01

NDC 0703-9040-93 [00703904093]

Amikacin Sulfate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064045
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-11-26
• Marketing End Date: 2016-09-30

NDC 0703-9040-01 [00703904001]

Amikacin Sulfate INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064045
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1993-10-01

Drug Details

Active Ingredients

Ingredient	Strength
AMIKACIN SULFATE	1 g/4mL

OpenFDA Data

• SPL SET ID: 6ec3129b-c53b-4bdb-913d-a2d0060fa140
• Manufacturer:
  • Teva Parenteral Medicines, Inc.
• UNII:
  • N6M33094FD
• RxNorm Concept Unique ID - RxCUI:
  • 1723156
  • 1723160

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]

NDC Crossover Matching brand name "Amikacin Sulfate" or generic name "Amikacin Sulfate"

NDC	Brand Name	Generic Name
0641-6166	Amikacin Sulfate	Amikacin Sulfate
0641-6167	Amikacin Sulfate	Amikacin Sulfate
0703-9032	Amikacin Sulfate	Amikacin Sulfate
0703-9040	Amikacin Sulfate	Amikacin Sulfate
23155-290	Amikacin Sulfate	Amikacin Sulfate
23155-785	Amikacin Sulfate	Amikacin Sulfate
23155-786	Amikacin Sulfate	Amikacin Sulfate
25021-173	amikacin sulfate	amikacin sulfate
63323-815	Amikacin Sulfate	Amikacin Sulfate