Talicia (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — Carton

NDC 57841-1150-2
Rx Only

Talicia®

(omeprazole magnesium,
amoxicillin, and rifabutin)
delayed-release capsules
10 mg*/250 mg/12.5 mg

2 BOTTLES x 84 CAPSULES

Talicia Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Bottle Label

NDC 57841-1150-1

Talicia®
(omeprazole magnesium,
amoxicillin, and rifabutin)
delayed-release capsules
10 mg*/250 mg/12.5 mg

Rx Only

84 CAPSULES

RedHill Biopharma

Talicia Bottle Label
(click image for full-size original)

TALICIA omeprazole magnesium, amoxicillin and rifabutin capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57841-1150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 10 mg
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 250 mg
RIFABUTIN (RIFABUTIN) RIFABUTIN 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C RED NO. 3
FD&C YELLOW NO. 6
GELATIN
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MEGLUMINE
STARCH, CORN
SILICON DIOXIDE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color orange Score no score
Shape capsule Size 20mm
Flavor Imprint Code RHB;105
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57841-1150-2 2 BOTTLE in 1 CARTON contains a BOTTLE (57841-1150-1)
1 NDC:57841-1150-1 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (57841-1150-2)
2 NDC:57841-1150-4 2 BOTTLE in 1 CARTON contains a BOTTLE (57841-1150-3)
2 NDC:57841-1150-3 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (57841-1150-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213004 03/09/2020
Labeler — RedHill Biopharma Ltd (533278342)

Revised: 09/2023 RedHill Biopharma Ltd

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