NDC 63323-815

Amikacin Sulfate

Amikacin Sulfate

Amikacin Sulfate is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Amikacin Sulfate.

Product ID63323-815_320bdbe8-fd78-4cd3-9436-50607439f219
NDC63323-815
Product TypeHuman Prescription Drug
Proprietary NameAmikacin Sulfate
Generic NameAmikacin Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2015-12-09
Marketing CategoryANDA / ANDA
Application NumberANDA205604
Labeler NameFresenius Kabi USA, LLC
Substance NameAMIKACIN SULFATE
Active Ingredient Strength250 mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-815-02

10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) > 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21)
Marketing Start Date2015-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-815-02 [63323081502]

Amikacin Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-12-09

NDC 63323-815-21 [63323081521]

Amikacin Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-08-25

NDC 63323-815-04 [63323081504]

Amikacin Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-12-09

NDC 63323-815-22 [63323081522]

Amikacin Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-08-25

Drug Details

Active Ingredients

IngredientStrength
AMIKACIN SULFATE250 mg/mL

OpenFDA Data

SPL SET ID:c0f57839-1c9b-49e5-8c7a-708e2d16495d
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0641-6166Amikacin SulfateAmikacin Sulfate
    0641-6167Amikacin SulfateAmikacin Sulfate
    0703-9032Amikacin SulfateAmikacin Sulfate
    0703-9040Amikacin SulfateAmikacin Sulfate
    23155-290Amikacin SulfateAmikacin Sulfate
    23155-785Amikacin SulfateAmikacin Sulfate
    23155-786Amikacin SulfateAmikacin Sulfate
    25021-173amikacin sulfateamikacin sulfate
    63323-815Amikacin SulfateAmikacin Sulfate
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