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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

NDC Product Code14789-700
Application NumberANDA204860
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 27, 2021
Generic NameProchlorperazine Edisylate

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

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Prochlorperazine Edisylate - FDA Drug Approval Details