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
NDC Product Code54348-114
Application NumberANDA040268
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 8, 2022
Generic NamePROCHLORPERAZINE
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