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NDC 63323-0367-11 Polymyxin B 500000 [USP'U]/1 Details
Polymyxin B 500000 [USP'U]/1
Polymyxin B is a INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is POLYMYXIN B SULFATE.
Product Information
| NDC | 63323-0367 |
|---|---|
| Product ID | 63323-367_5cf9b65b-6df4-42f8-b395-d0cf0a1003d3 |
| Associated GPIs | 16100010102105 |
| GCN Sequence Number | 009354 |
| GCN Sequence Number Description | polymyxin B sulfate VIAL 500K UNIT INJECTION |
| HIC3 | W1N |
| HIC3 Description | POLYMYXIN ANTIBIOTICS AND DERIVATIVES |
| GCN | 41320 |
| HICL Sequence Number | 004049 |
| HICL Sequence Number Description | POLYMYXIN B SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Polymyxin B |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Polymyxin B Sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS |
| Active Ingredient Strength | 500000 |
| Active Ingredient Units | [USP'U]/1 |
| Substance Name | POLYMYXIN B SULFATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202766 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0367-11 (63323036711)
| NDC Package Code | 63323-367-11 |
|---|---|
| Billing NDC | 63323036711 |
| Package | 10 VIAL in 1 CARTON (63323-367-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-367-01) |
| Marketing Start Date | 2015-09-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |