Naloxone Hydrochloride
Approved
Approval ID
236349ef-2cb5-47ca-a3a5-99534c3a4996
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2022
Manufacturers
FDA
International Medication Systems, Limited
DUNS: 055750020
Products 2
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 Code76329-1469
Application NumberANDA072076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naloxone Hydrochloride
Product Specifications
Route of AdministrationPARENTERAL
Effective DateNovember 18, 2016
FDA Product Classification
INGREDIENTS (1)
Naloxone HydrochlorideActive
Quantity: 1 mg in 1 mL
Code: F850569PQR
Classification: ACTIB
Naloxone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76329-3369
Application NumberANDA072076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naloxone Hydrochloride
Product Specifications
Route of AdministrationPARENTERAL
Effective DateNovember 18, 2016
FDA Product Classification
INGREDIENTS (1)
Naloxone HydrochlorideActive
Quantity: 1 mg in 1 mL
Code: F850569PQR
Classification: ACTIB