POLYMYXIN B is a Intramuscular; Intrathecal; Intravenous; Ophthalmic Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Polymyxin B Sulfate.
| Product ID | 68083-174_3884f083-2d69-4a04-9ae4-d34708b915c3 |
| NDC | 68083-174 |
| Product Type | Human Prescription Drug |
| Proprietary Name | POLYMYXIN B |
| Generic Name | Polymyxin B Sulfate |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC |
| Marketing Start Date | 2016-06-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207322 |
| Labeler Name | Gland Pharma Limited |
| Substance Name | POLYMYXIN B SULFATE |
| Active Ingredient Strength | 500000 [USP'U]/1 |
| Pharm Classes | Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2016-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207322 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-06-01 |
| Marketing Category | ANDA |
| Application Number | ANDA207322 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-06-01 |
| Ingredient | Strength |
|---|---|
| POLYMYXIN B SULFATE | 500000 1/1 |
| SPL SET ID: | dc74dee2-1d0b-4fab-a29b-1755fdb5da75 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9941 | Polymyxin B | Polymyxin B sulfate |
| 39822-0166 | Polymyxin B | Polymyxin B |
| 39822-0170 | Polymyxin B | Polymyxin B |
| 39822-0171 | Polymyxin B | Polymyxin B |
| 45932-0030 | POLYMYXIN B | POLYMYXIN B SULFATE |
| 47781-596 | Polymyxin B | polymyxin B sulfate |
| 51991-939 | Polymyxin B | Polymyxin B |
| 55150-234 | Polymyxin B | Polymyxin B |
| 63323-321 | POLYMYXIN B | POLYMYXIN B SULFATE |
| 63323-367 | POLYMYXIN B | POLYMYXIN B SULFATE |
| 68083-174 | POLYMYXIN B | POLYMYXIN B SULFATE |
| 70594-049 | Polymyxin B | Polymyxin B Sulfate |
| 70860-103 | Polymyxin B | polymyxin B sulfate |
| 70860-124 | Polymyxin B | polymyxin B sulfate |