Prochlorperazine Edisylate
PROCHLORPERAZINE EDISYLATE - prochlorperazine edisylate injection
Approved
Approval ID
ed9e300a-c577-4c78-a806-3a586ab5f1c7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2021
Manufacturers
FDA
Nexus Pharmaceuticals Inc.
DUNS: 620714787
FDA
Nexus Pharmaceuticals LLC
DUNS: 620714787
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 Code14789-700
Application NumberANDA204860
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prochlorperazine Edisylate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 27, 2021
FDA Product Classification
INGREDIENTS (7)
Prochlorperazine EdisylateActive
Quantity: 5 mg in 1 mL
Code: PG20W5VQZS
Classification: ACTIM
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM TARTRATEInactive
Code: QTO9JB4MDD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROCHLORPERAZINE EDISYLATEActive
Quantity: 5 mg in 1 mL
Code: PG20W5VQZS
Classification: ACTIM