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NDC 39822-0615-02 Colistimethate 150 mg/2mL Details
Colistimethate 150 mg/2mL
Colistimethate is a INTRAMUSCULAR; 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 COLISTIMETHATE SODIUM.
MedlinePlus Drug Summary
Colistimethate injection is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria. Antibiotics such as colistimethate injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 39822-0615-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Colistimethate Injection
Product Information
| NDC | 39822-0615 |
|---|---|
| Product ID | 39822-0615_eedca302-5a83-6a5c-e053-2a95a90a7144 |
| Associated GPIs | 16100004202132 |
| GCN Sequence Number | 009357 |
| GCN Sequence Number Description | colistin (colistimethate Na) VIAL 150 MG INJECTION |
| HIC3 | W1N |
| HIC3 Description | POLYMYXIN ANTIBIOTICS AND DERIVATIVES |
| GCN | 41350 |
| HICL Sequence Number | 004051 |
| HICL Sequence Number Description | COLISTIN (AS COLISTIMETHATE SODIUM) |
| Brand/Generic | Generic |
| Proprietary Name | Colistimethate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Colistimethate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 150 |
| Active Ingredient Units | mg/2mL |
| Substance Name | COLISTIMETHATE SODIUM |
| Labeler Name | XGen Pharmaceuticals DJB, Inc. |
| Pharmaceutical Class | Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA064216 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 39822-0615-02 (39822061502)
| NDC Package Code | 39822-0615-2 |
|---|---|
| Billing NDC | 39822061502 |
| Package | 12 CARTON in 1 CARTON (39822-0615-2) / 1 VIAL in 1 CARTON (39822-0615-1) / 2 mL in 1 VIAL |
| Marketing Start Date | 2011-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |