Tarpeyo
These highlights do not include all the information needed to use TARPEYO safely and effectively. See full prescribing information for TARPEYO. TARPEYO (budesonide) delayed release capsules, for oral useInitial U.S. Approval: 1997
Approved
Approval ID
938cada4-d6bf-4252-836f-dd40f9eadb4d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
Calliditas Therapeutics AB
DUNS: 351157735
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
budesonide
PRODUCT DETAILS
NDC Product Code81749-004
Application NumberNDA215935
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 21, 2021
Generic Namebudesonide
INGREDIENTS (19)
budesonideActive
Quantity: 4 mg in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Hypromellose 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
Hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
hypromellose 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
Polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Ethylcellulose (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
Medium-chain triglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
Oleic acidInactive
Code: 2UMI9U37CP
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Dibutyl sebacateInactive
Code: 4W5IH7FLNY
Classification: IACT
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)Inactive
Code: 5KY68S2577
Classification: IACT