Naloxone Hydrochloride
Naloxone Hydrochloride Injection, USP
Approved
Approval ID
7faaedb3-227b-408d-b772-6b326638b00e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-992
Application NumberANDA213843
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naloxone Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateOctober 22, 2021
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
NALOXONE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: F850569PQR
Classification: ACTIM
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/22/2021