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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-688
Application NumberANDA216202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prochlorperazine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-689
Application NumberANDA216202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prochlorperazine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
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