OXACILLIN
Oxacillin Injection, USP in Plastic Container For Intravenous Use Only GALAXY Container (PL 2040)
Approved
Approval ID
d893e45b-7f18-4c67-b10c-1e2e52a6b3ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2018
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OXACILLIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-1013
Application NumberNDA050640
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXACILLIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 24, 2017
FDA Product Classification
INGREDIENTS (6)
DEXTROSE MONOHYDRATEInactive
Quantity: 1.5 g in 50 mL
Code: LX22YL083G
Classification: IACT
OXACILLIN SODIUMActive
Quantity: 1 g in 50 mL
Code: G0V6C994Q5
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 150 mg in 50 mL
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
OXACILLIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-1015
Application NumberNDA050640
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXACILLIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 24, 2017
FDA Product Classification
INGREDIENTS (6)
DEXTROSE MONOHYDRATEInactive
Quantity: 300 mg in 50 mL
Code: LX22YL083G
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 300 mg in 50 mL
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXACILLIN SODIUMActive
Quantity: 2 g in 50 mL
Code: G0V6C994Q5
Classification: ACTIM