Talicia
These highlights do not include all the information needed to use TALICIA safely and effectively. See full prescribing information for TALICIA. TALICIA (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules, for oral use Initial U.S. Approval: 2019
Approved
Approval ID
68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2023
Manufacturers
FDA
RedHill Biopharma Ltd
DUNS: 533278342
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
omeprazole magnesium, amoxicillin and rifabutin
PRODUCT DETAILS
NDC Product Code57841-1150
Application NumberNDA213004
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 22, 2021
Generic Nameomeprazole magnesium, amoxicillin and rifabutin
INGREDIENTS (20)
RIFABUTINActive
Quantity: 12.5 mg in 1 1
Code: 1W306TDA6S
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
OMEPRAZOLE MAGNESIUMActive
Quantity: 10 mg in 1 1
Code: 426QFE7XLK
Classification: ACTIM
AMOXICILLINActive
Quantity: 250 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT