NALOXONE HYDROCHLORIDE
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1971
Approved
Approval ID
6c9a1e1f-e324-405b-b578-41defae3c8ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2023
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83008-007
Application NumberANDA211951
Product Classification
M
Marketing Category
C73584
G
Generic Name
naloxone hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 3, 2023
FDA Product Classification
INGREDIENTS (6)
NALOXONE HYDROCHLORIDEActive
Quantity: 4 mg in 0.1 mL
Code: F850569PQR
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT