Basic Information
budesonide
68682-658
Regulatory Information
68682-658
NDA205613
C73594
October 1, 2021
USA
These highlights do not include all the information needed to use BUDESONIDE RECTAL FOAM safely and effectively. See full prescribing information for BUDESONIDE RECTAL FOAM.BUDESONIDE rectal foamInitial U.S. Approval: 1997
HUMAN PRESCRIPTION DRUG LABEL
4
Company Information
832011691
Active Ingredients
Inactive Ingredients
CETYL ALCOHOL
Code: 936JST6JCN
Class Code: IACT
CITRIC ACID MONOHYDRATE
Code: 2968PHW8QP
Class Code: IACT
CETOSTEARYL ALCOHOL
Code: 2DMT128M1S
Class Code: IACT
POLYSORBATE 60
Code: CAL22UVI4M
Class Code: IACT
STEARETH-10
Code: FD0913P475
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
BUTANE
Code: 6LV4FOR43R
Class Code: IACT
ISOBUTANE
Code: BXR49TP611
Class Code: IACT
EDETATE DISODIUM
Code: 7FLD91C86K
Class Code: IACT
PROPANE
Code: T75W9911L6
Class Code: IACT
Active Moieties
BUDESONIDE
Code: Q3OKS62Q6X