NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE INJECTION, USP 0.4mg/mL 1mL CARP
Approved
Approval ID
74fcd243-94b3-ec77-e053-2991aa0a229c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2022
Manufacturers
FDA
HF Acquisition Co. LLC, DBA HealthFirst
DUNS: 045657305
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 Code51662-1238
Application NumberANDA070172
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 9, 2022
Generic NameNALOXONE HYDROCHLORIDE
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
NALOXONE HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 mL
Code: F850569PQR
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT