Prochlorperazine Edisylate
Rx only
Approved
Approval ID
f793cdb3-9fd8-79e1-e053-6394a90ae08b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 4, 2023
Manufacturers
FDA
FOSUN PHARMA USA INC
DUNS: 080920998
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prochlorperazine Edisylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72266-204
Application NumberANDA214107
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prochlorperazine Edisylate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 4, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 5 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
SACCHARIN SODIUMInactive
Quantity: 0.9 mg in 1 mL
Code: SB8ZUX40TY
Classification: IACT
SODIUM TARTRATE DIHYDRATEInactive
Quantity: 12 mg in 1 mL
Code: DIA7C37AOW
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 7.5 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
PROCHLORPERAZINE EDISYLATEActive
Quantity: 5 mg in 1 mL
Code: PG20W5VQZS
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT