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NDC 63323-0815-02 Amikacin Sulfate 250 mg/mL Details
Amikacin Sulfate 250 mg/mL
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.
MedlinePlus Drug Summary
Amikacin injection is used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract. Amikacin injection is in a class of medications called aminoglycoside antibiotics. It works by killing bacteria. Antibiotics such as amikacin injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 63323-0815-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Amikacin Injection
Product Information
| NDC | 63323-0815 |
|---|---|
| Product ID | 63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6 |
| Associated GPIs | 07000010102011 07000010102013 |
| GCN Sequence Number | 066447 |
| GCN Sequence Number Description | amikacin sulfate VIAL 500 MG/2ML INJECTION |
| HIC3 | W1F |
| HIC3 Description | AMINOGLYCOSIDE ANTIBIOTICS |
| GCN | 28729 |
| HICL Sequence Number | 004035 |
| HICL Sequence Number Description | AMIKACIN SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Amikacin Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Amikacin Sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/mL |
| Substance Name | AMIKACIN SULFATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205604 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0815-02 (63323081502)
| NDC Package Code | 63323-815-02 |
|---|---|
| Billing NDC | 63323081502 |
| Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21) |
| Marketing Start Date | 2015-12-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |