BUDESONIDE (ENTERIC COATED)
These highlights do not include all the information needed to use BUDESONIDE capsules (enteric coated) safely and effectively. See full prescribing information for BUDESONIDE capsules (enteric coated). BUDESONIDE extended-release capsules (enteric coated), for oral use Initial U.S. Approval: 1997
Approved
Approval ID
0659420e-e376-4b90-98bf-71af41c18676
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2022
Manufacturers
FDA
Mayne Pharma Inc.
DUNS: 867220261
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 Code51862-580
Application NumberANDA206623
Product Classification
M
Marketing Category
C73584
G
Generic Name
Budesonide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2019
FDA Product Classification
INGREDIENTS (23)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
BudesonideActive
Quantity: 3 mg in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
Acetyltributyl citrateInactive
Code: 0ZBX0N59RZ
Classification: IACT
Ethylcellulose (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT