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NDC 39822-0412-01 Tobramycin 1.2 g/30mL Details
Tobramycin 1.2 g/30mL
Tobramycin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by XGen Pharmaceuticals DJB, Inc.. The primary component is TOBRAMYCIN SULFATE.
MedlinePlus Drug Summary
Tobramycin 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. Tobramycin injection is in a class of medications called aminoglycoside antibiotics. It works by killing bacteria. Antibiotics such as tobramycin 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: 39822-0412-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tobramycin Injection
Product Information
| NDC | 39822-0412 |
|---|---|
| Product ID | 39822-0412_f7047d2d-2b45-7a75-e053-6294a90a49a0 |
| Associated GPIs | 07000070102105 |
| GCN Sequence Number | 009308 |
| GCN Sequence Number Description | tobramycin sulfate VIAL 1.2 G INJECTION |
| HIC3 | W1F |
| HIC3 Description | AMINOGLYCOSIDE ANTIBIOTICS |
| GCN | 41160 |
| HICL Sequence Number | 004034 |
| HICL Sequence Number Description | TOBRAMYCIN SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Tobramycin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tobramycin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1.2 |
| Active Ingredient Units | g/30mL |
| Substance Name | TOBRAMYCIN SULFATE |
| Labeler Name | XGen Pharmaceuticals DJB, Inc. |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA065013 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 39822-0412-01 (39822041201)
| NDC Package Code | 39822-0412-1 |
|---|---|
| Billing NDC | 39822041201 |
| Package | 1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL |
| Marketing Start Date | 2001-08-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |