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
NDC Product Code70069-072
Application NumberANDA207634
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 19, 2023
Generic NameNaloxone Hydrochloride
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