Mycapssa
These highlights do not include all the information needed to use MYCAPSSA safely and effectively. See full prescribing information for MYCAPSSA. MYCAPSSA (octreotide) delayed-release capsules, for oral use Initial U.S. Approval: 1988
Approved
Approval ID
58d80bc6-bdfb-4908-93e7-aace447c8d1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Chiesi USA, Inc.
DUNS: 088084228
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Octreotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10122-550
Application NumberNDA208232
Product Classification
M
Marketing Category
C73594
G
Generic Name
Octreotide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (19)
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRICAPRILINInactive
Code: 6P92858988
Classification: IACT
OctreotideActive
Quantity: 20 mg in 1 1
Code: RWM8CCW8GP
Classification: ACTIB
POVIDONE K12Inactive
Code: 333AG72FWJ
Classification: IACT
sodium caprylateInactive
Code: 9XTM81VK2B
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
glyceryl monocaprylateInactive
Code: TM2TZD4G4A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT