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
NDC Product Code83008-007
Application NumberANDA211951
Marketing CategoryC73584
Route of AdministrationNASAL
Effective DateMarch 3, 2023
Generic Namenaloxone hydrochloride
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