Basic Information
BUDESONIDE (ENTERIC COATED)
51407-128
Regulatory Information
51407-128
ANDA206623
C73584
January 8, 2024
USA
BUDESONIDE capsules. 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
HUMAN PRESCRIPTION DRUG LABEL
4
Company Information
603184490
Active Ingredients
Inactive Ingredients
ACETYLTRIBUTYL CITRATE
Code: 0ZBX0N59RZ
Class Code: IACT
ETHYLCELLULOSE (10 MPA.S)
Code: 3DYK7UYZ62
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Code: NX76LV5T8J
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
D&C RED NO. 28
Code: 767IP0Y5NH
Class Code: IACT
D&C RED NO. 33
Code: 9DBA0SBB0L
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
Active Moieties
BUDESONIDE
Code: Q3OKS62Q6X