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NDC 39822-1201-02 Neomycin and Polymyxin B Sulfates 40; 200000 mg/mL; [USP'U]/mL Details
Neomycin and Polymyxin B Sulfates 40; 200000 mg/mL; [USP'U]/mL
Neomycin and Polymyxin B Sulfates is a IRRIGATION SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by XGen Pharmaceuticals DJB, Inc.. The primary component is NEOMYCIN SULFATE; POLYMYXIN B SULFATE.
Product Information
| NDC | 39822-1201 |
|---|---|
| Product ID | 39822-1201_0cc9b11c-90cb-c93a-e063-6294a90ab1eb |
| Associated GPIs | 56701002102000 |
| GCN Sequence Number | 009832 |
| GCN Sequence Number Description | neomycin sulf/polymyxin B sulf AMPUL 40-200K/ML IRRIGATION |
| HIC3 | W8F |
| HIC3 Description | IRRIGANTS |
| GCN | 89699 |
| HICL Sequence Number | 003369 |
| HICL Sequence Number Description | NEOMYCIN SULFATE/POLYMYXIN B SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Neomycin and Polymyxin B Sulfates |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Neomycin and Polymyxin B Sulfates |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | IRRIGATION |
| Active Ingredient Strength | 40; 200000 |
| Active Ingredient Units | mg/mL; [USP'U]/mL |
| Substance Name | NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
| Labeler Name | XGen Pharmaceuticals DJB, Inc. |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA065106 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 39822-1201-02 (39822120102)
| NDC Package Code | 39822-1201-2 |
|---|---|
| Billing NDC | 39822120102 |
| Package | 10 AMPULE in 1 CARTON (39822-1201-2) / 1 mL in 1 AMPULE (39822-1201-1) |
| Marketing Start Date | 2006-01-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |