Naloxone Hydrochloride
Naloxone Hydrochloride Injection, USP USP type-I clear tubular glass Vial, Opioid Antagonist Protect from light by retaining in the carton until ready for use. Discard unused portion. Rx only
Approved
Approval ID
b59ee3cc-9604-4abc-81be-897e2f42aa67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
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 Code70069-072
Application NumberANDA207634
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naloxone Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (6)
NALOXONE HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 mL
Code: F850569PQR
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT