Prochlorperazine Maleate
PROCHLORPERAZINE MALEATE TABLETS, USP Rx only
Approved
Approval ID
50ce4381-94ef-49ff-8794-cfde0ee803b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prochlorperazine Maleate
PRODUCT DETAILS
NDC Product Code70954-688
Application NumberANDA216202
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameProchlorperazine Maleate
INGREDIENTS (9)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
PROCHLORPERAZINE MALEATEActive
Quantity: 5 mg in 1 1
Code: I1T8O1JTL6
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Prochlorperazine Maleate
PRODUCT DETAILS
NDC Product Code70954-689
Application NumberANDA216202
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameProchlorperazine Maleate
INGREDIENTS (9)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROCHLORPERAZINE MALEATEActive
Quantity: 10 mg in 1 1
Code: I1T8O1JTL6
Classification: ACTIM
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT