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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82432-102
Application NumberANDA216007
Product Classification
M
Marketing Category
C73584
G
Generic Name
nalmefene hydrochloride injection
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateDecember 8, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82432-101
Application NumberANDA216007
Product Classification
M
Marketing Category
C73584
G
Generic Name
nalmefene hydrochloride injection
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateDecember 8, 2023
FDA Product Classification
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