KLOXXADO
These highlights do not include all the information needed to use KLOXXADO safely and effectively. See full prescribing information for KLOXXADO.KLOXXADO (naloxone hydrochloride) nasal sprayInitial U.S. Approval: 1971
Approved
Approval ID
ebf0f833-c1c0-487c-8f29-01fa8c61b6cb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2022
Manufacturers
FDA
Hikma Specialty USA Inc.
DUNS: 078883518
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naloxone HCL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59467-679
Application NumberNDA212045
Product Classification
M
Marketing Category
C73594
G
Generic Name
Naloxone HCL
Product Specifications
Route of AdministrationNASAL
Effective DateMay 10, 2022
FDA Product Classification
INGREDIENTS (7)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
NALOXONE HYDROCHLORIDEActive
Quantity: 8 mg in 0.1 mL
Code: F850569PQR
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT