nalmefene hydrochloride
Approved
Approval ID
22d67228-6c24-47ca-afc7-52ef279520a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Chengdu Shuode Pharmaceutical Co., Ltd
DUNS: 408709974
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nalmefene hydrochloride injection
PRODUCT DETAILS
NDC Product Code82432-102
Application NumberANDA216007
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateDecember 8, 2023
Generic Namenalmefene hydrochloride injection
INGREDIENTS (4)
NALMEFENE HYDROCHLORIDEActive
Quantity: 2 mg in 2 mL
Code: K7K69QC05X
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
nalmefene hydrochloride injection
PRODUCT DETAILS
NDC Product Code82432-101
Application NumberANDA216007
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateDecember 8, 2023
Generic Namenalmefene hydrochloride injection
INGREDIENTS (4)
NALMEFENE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 mL
Code: K7K69QC05X
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT