APOKYN
These highlights do not include all the information needed to use APOKYN safely and effectively. See full prescribing information for APOKYN . APOKYN (apomorphine hydrochloride injection), for subcutaneous use Initial U.S. Approval: 2004
Approved
Approval ID
3235535d-9ef9-4657-8b2a-176a807d091c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
MDD US Operations, LLC
DUNS: 087875626
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
APOMORPHINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27505-004
Application NumberNDA021264
Product Classification
M
Marketing Category
C73594
G
Generic Name
APOMORPHINE HYDROCHLORIDE
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (6)
BENZYL ALCOHOLInactive
Quantity: 15 mg in 3 mL
Code: LKG8494WBH
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 3 mg in 3 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
APOMORPHINE HYDROCHLORIDEActive
Quantity: 30 mg in 3 mL
Code: F39049Y068
Classification: ACTIB