cocaine hydrochloride nasal
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Cocaine Hydrochloride nasal solution, CII Initial U.S. Approval: 2017
Approved
Approval ID
4e3b2f6b-1b57-40bc-872b-01c0a3c7986e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2023
Manufacturers
FDA
OMNIVIUM PHARMACEUTICALS LLC.
DUNS: 117919347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cocaine hydrochloride nasal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81665-301
Application NumberNDA209575
Product Classification
M
Marketing Category
C73605
G
Generic Name
cocaine hydrochloride nasal
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (6)
COCAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: XH8T8T6WZH
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT