Naloxone Hydrochloride
Naloxone Hydrochloride Injection, USP Rx only
Approved
Approval ID
5de44ee7-6525-4857-9a67-8882e96dbeb5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2023
Manufacturers
FDA
BPI Labs LLC
DUNS: 078627620
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 Code54288-124
Application NumberANDA216977
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naloxone Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateOctober 17, 2023
FDA Product Classification
INGREDIENTS (4)
NALOXONE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: F850569PQR
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 8.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT