Naloxone Hydrochloride
NALOXONE HYDROCHLORIDE
Approved
Approval ID
2d53f70f-3c6d-6934-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2019
Manufacturers
FDA
Sina Health Inc
DUNS: 047161553
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 Code70385-2013
Application NumberANDA070256
Product Classification
M
Marketing Category
C73584
G
Generic Name
NALOXONE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR
Effective DateFebruary 4, 2019
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NALOXONE HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 mL
Code: F850569PQR
Classification: ACTIB