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NDC 63323-0010-94 Gentamicin 40 mg/mL Details
Gentamicin 40 mg/mL
Gentamicin 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 GENTAMICIN SULFATE.
MedlinePlus Drug Summary
Gentamicin 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. Gentamicin injection is in a class of medications called aminoglycoside antibiotics. It works by killing bacteria. Antibiotics such as gentamicin 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: 63323-0010-94Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Gentamicin Injection
Product Information
| NDC | 63323-0010 |
|---|---|
| Product ID | 63323-010_cf4327d0-9155-4a07-9c54-51592b66b817 |
| Associated GPIs | 07000020102045 |
| GCN Sequence Number | 009299 |
| GCN Sequence Number Description | gentamicin sulfate VIAL 40 MG/ML INJECTION |
| HIC3 | W1F |
| HIC3 Description | AMINOGLYCOSIDE ANTIBIOTICS |
| GCN | 41132 |
| HICL Sequence Number | 004032 |
| HICL Sequence Number Description | GENTAMICIN SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Gentamicin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | GENTAMICIN SULFATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/mL |
| Substance Name | GENTAMICIN SULFATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA062366 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0010-94 (63323001094)
| NDC Package Code | 63323-010-94 |
|---|---|
| Billing NDC | 63323001094 |
| Package | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-94) / 2 mL in 1 VIAL, MULTI-DOSE (63323-010-41) |
| Marketing Start Date | 2000-08-10 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.69103 |
| Pricing Unit | ML |
| Effective Date | 2021-08-18 |
| NDC Description | GENTAMICIN 80 MG/2 ML VIAL |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-08-10 |