POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
Approved
Approval ID
1a01d41b-3da1-4938-9e71-499320c72dd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2023
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-233
Application NumberNDA050567
Product Classification
M
Marketing Category
C73605
G
Generic Name
POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 11, 2023
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
TRIMETHOPRIM SULFATEActive
Quantity: 1 mg in 1 mL
Code: E377MF8EQ8
Classification: ACTIM