NDC 0641-6167

Amikacin Sulfate

Amikacin Sulfate

Amikacin Sulfate is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Amikacin Sulfate.

• Product ID: 0641-6167_c1595a19-436d-4757-9223-76990ccf0120
• NDC: 0641-6167
• Product Type: Human Prescription Drug
• Proprietary Name: Amikacin Sulfate
• Generic Name: Amikacin Sulfate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2015-08-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA063315
• Labeler Name: West-Ward Pharmaceuticals Corp.
• Substance Name: AMIKACIN SULFATE
• Active Ingredient Strength: 250 mg/mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0641-6167-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6167-10) > 2 mL in 1 VIAL, SINGLE-DOSE (0641-6167-01)

• Marketing Start Date: 2015-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0641-6167-01 [00641616701]

Amikacin Sulfate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA063315
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-01

NDC 0641-6167-25 [00641616725]

Amikacin Sulfate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA063315
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-08-01
• Marketing End Date: 2015-11-18

NDC 0641-6167-10 [00641616710]

Amikacin Sulfate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA063315
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-01

Drug Details

Active Ingredients

Ingredient	Strength
AMIKACIN SULFATE	250 mg/mL

OpenFDA Data

• SPL SET ID: 0b56f6df-a05d-4520-8bf0-d7cefe20f6ad
• Manufacturer:
  • West-Ward Pharmaceuticals Corp.
• UNII:
  • N6M33094FD
• RxNorm Concept Unique ID - RxCUI:
  • 1723156
  • 1723160

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]
• 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