Naloxone Hydrochloride
Naloxone Hydrochloride 1mg/1ml 2ml Syringe
Approved
Approval ID
67130add-b80a-4a81-9750-1ebf2912da59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6259
Application NumberANDA072076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naloxone Hydrochloride
Product Specifications
Route of AdministrationPARENTERAL
Effective DateMay 9, 2011
FDA Product Classification
INGREDIENTS (3)
Naloxone HydrochlorideActive
Quantity: 1 mg in 1 mL
Code: F850569PQR
Classification: ACTIB
Sodium ChlorideInactive
Quantity: 8.35 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT