Compro
Rx only
Approved
Approval ID
ea381bc5-0957-4c91-826a-0ff680cebacc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2023
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROCHLORPERAZINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-7226
Application NumberANDA040246
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROCHLORPERAZINE
Product Specifications
Route of AdministrationRECTAL
Effective DateDecember 6, 2016
FDA Product Classification
INGREDIENTS (6)
PROCHLORPERAZINEActive
Quantity: 25 mg in 1 1
Code: YHP6YLT61T
Classification: ACTIB
GLYCERYL PALMITATEInactive
Code: 6Y2XJ05B35
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HYDROGENATED COCONUT OILInactive
Code: JY81OXM1OM
Classification: IACT
HYDROGENATED PALM KERNEL OILInactive
Code: FM8D1RE2VP
Classification: IACT