ENTOCORT
ENTOCORT® EC (budesonide) CAPSULES
Approved
Approval ID
fe6530ef-1b23-451f-1290-0e3ef02ec1b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 24, 2009
Manufacturers
FDA
Prometheus Laboratories Inc
DUNS: 967000860
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Budesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65483-702
Application NumberNDA021324
Product Classification
M
Marketing Category
C73594
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2012
FDA Product Classification
INGREDIENTS (12)
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
BUDESONIDEActive
Quantity: 3 mg in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT