PROCHLORPERAZINE
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only
Approved
Approval ID
888f253f-1db1-45bc-8fc7-15f97ff0ba18
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2022
Manufacturers
FDA
PharmPak, Inc.
DUNS: 175493840
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROCHLORPERAZINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54348-114
Application NumberANDA040268
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROCHLORPERAZINE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 8, 2022
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROCHLORPERAZINE MALEATEActive
Quantity: 10 mg in 1 1
Code: I1T8O1JTL6
Classification: ACTIM
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT