COCAINE HYDROCHLORIDE
These highlights do not include all the information needed to use COCAINE HYDROCHLORIDE nasal solution safely and effectively. See full prescribing information for COCAINE HYDROCHLORIDE nasal solution. COCAINE HYDROCHLORIDE nasal solution, for intranasal use, CII Initial U.S. Approval: 2017
Approved
Approval ID
0fb0298f-9756-26e8-e063-6294a90ae8f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
LXO US INC.
DUNS: 932134773
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
COCAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70839-362
Application NumberNDA209963
Product Classification
M
Marketing Category
C73605
G
Generic Name
COCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationNASAL
Effective DateJanuary 25, 2024
FDA Product Classification
INGREDIENTS (6)
COCAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: XH8T8T6WZH
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT