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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57841-1150
Application NumberNDA213004
Product Classification
M
Marketing Category
C73594
G
Generic Name
omeprazole magnesium, amoxicillin and rifabutin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2021
FDA Product Classification
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