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NDC 68083-0569-01 Vancomycin Hydrochloride 5 g/100mL Details
Vancomycin Hydrochloride 5 g/100mL
Vancomycin Hydrochloride is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Gland Pharma Limited. The primary component is VANCOMYCIN HYDROCHLORIDE.
MedlinePlus Drug Summary
Vancomycin injection is used alone or in combination with other medications to treat certain serious infections such as endocarditis (infection of the heart lining and valves), peritonitis (inflammation of the lining of the abdomen), and infections of the lungs, skin, blood, and bones. Vancomycin injection is in a class of medications called glycopeptide antibiotics. It works by killing bacteria that cause infections. Antibiotics such as vancomycin injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 68083-0569-01Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Vancomycin Injection
Product Information
| NDC | 68083-0569 |
|---|---|
| Product ID | 68083-569_c45949e7-eaef-4e97-8a8e-9134855ee6a4 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Vancomycin Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Vancomycin Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | g/100mL |
| Substance Name | VANCOMYCIN HYDROCHLORIDE |
| Labeler Name | Gland Pharma Limited |
| Pharmaceutical Class | Glycopeptide Antibacterial [EPC], Glycopeptides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205694 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68083-0569-01 (68083056901)
| NDC Package Code | 68083-569-01 |
|---|---|
| Billing NDC | 68083056901 |
| Package | 1 BOTTLE in 1 CARTON (68083-569-01) / 100 mL in 1 BOTTLE |
| Marketing Start Date | 2023-06-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |