NDC 25021-173

amikacin sulfate

Amikacin Sulfate

amikacin sulfate is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is Amikacin Sulfate.

Product ID25021-173_1a4b8248-8d54-487c-b57c-a4192a265749
NDC25021-173
Product TypeHuman Prescription Drug
Proprietary Nameamikacin sulfate
Generic NameAmikacin Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-06-15
Marketing CategoryANDA / ANDA
Application NumberANDA203323
Labeler NameSagent Pharmaceuticals
Substance NameAMIKACIN SULFATE
Active Ingredient Strength250 mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 25021-173-02

10 VIAL in 1 CARTON (25021-173-02) > 2 mL in 1 VIAL
Marketing Start Date2016-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-173-04 [25021017304]

amikacin sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA203323
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-06-15

NDC 25021-173-02 [25021017302]

amikacin sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA203323
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-06-15

Drug Details

Active Ingredients

IngredientStrength
AMIKACIN SULFATE250 mg/mL

OpenFDA Data

SPL SET ID:f260ff2a-76a0-4672-9516-91c344b67890
Manufacturer
UNII
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"

    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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