Pimozide
Pimozide Tablets, USP
Approved
Approval ID
70b079e2-a1f7-4a93-8685-d60a4d7c1280
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 25, 2017
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pimozide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-348
Application NumberANDA204521
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pimozide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2017
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PIMOZIDEActive
Quantity: 2 mg in 1 1
Code: 1HIZ4DL86F
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Pimozide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-347
Application NumberANDA204521
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pimozide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2017
FDA Product Classification
INGREDIENTS (5)
PIMOZIDEActive
Quantity: 1 mg in 1 1
Code: 1HIZ4DL86F
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT