PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE TABLETS USPRx Only
Approved
Approval ID
a9111024-b249-4974-b174-d0b98a492ac0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2013
Manufacturers
FDA
Liberty Pharmaceuticals, Inc.
DUNS: 012568840
Products 1
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 Code0440-8190
Application NumberANDA040268
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 11, 2013
Generic NameProchlorperazine Maleate
INGREDIENTS (14)
PROCHLORPERAZINE MALEATEActive
Quantity: 5 mg in 1 1
Code: I1T8O1JTL6
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 4/8/2010