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
NDC Product Code59011-960
Application NumberANDA212955
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 1, 2023
Generic NameNALMEFENE HYDROCHLORIDE
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