NALMEFENE HYDROCHLORIDE
Nalmefene Hydrochloride Injection
Approved
Approval ID
3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
Purdue Pharma L.P.
DUNS: 932323652
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NALMEFENE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59011-960
Application NumberANDA212955
Product Classification
M
Marketing Category
C73584
G
Generic Name
NALMEFENE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (4)
NALMEFENE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: K7K69QC05X
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT