(rivaroxaban)
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XARELTO® (rivaroxaban)
Medical Information
XARELTO - How Supplied
Last Updated: 06/20/2024
SUMMARY
- XARELTO is supplied in the United States as a tablet (2.5 mg, 10 mg, 15 mg, and 20 mg) and granules in an amber glass bottle (1 mg/mL oral suspension once reconstituted).1
PRODUCT LABELING
Please refer to the following sections of the enclosed Full Prescribing Information1 that are relevant to your inquiry: DOSAGE FORMS AND STRENGTHS and HOW SUPPLIED/STORAGE AND HANDLING.
XARELTO (rivaroxaban) tablets are available in the strengths and packages listed below:
The 2.5 mg tablets are round, light yellow, and film-coated with a triangle pointing down above a “2.5” marked on one side and “Xa” on the other side.1 See Figures: Xa (2.5 mg) Front and 2.5 mg Rear. The tablets are 6 mm in diameter and have an average thickness of 2.8 mm.2
The 10 mg tablets are round, light red, biconvex and film-coated with a triangle pointing down above a “10” marked on one side and “Xa” on the other side.1 See Figures: Xa (10 mg) Front and 10 mg Rear. The tablets are 6 mm in diameter and have an average thickness of 2.7 mm.2,4
The 15 mg tablets are round, red, biconvex, and film-coated with a triangle pointing down above a “15” marked on one side and “Xa” on the other side.1 See Figures: Xa (15 mg) Front and 15 mg Rear. The tablets are 6 mm in diameter and have an average thickness of 2.97 mm.2,5
The 20 mg tablets are triangle-shaped, dark red, and film-coated with a triangle pointing down above a “20” marked on one side and “Xa” on the other side.1 See Figures: Xa (20 mg) Front and 20 mg Rear. The tablets are 6.6 mm on each side and have an average thickness of 2.84 mm.2,6
The Starter Pack for treatment of deep vein thrombosis and treatment of pulmonary embolism is a 30-day starter blister pack containing 51 tablets: 42 tablets of 15 mg and 9 tablets of 20 mg.1 See Figures: Starter Pack and Starter Pack Interior and Contents.
See Table: XARELTO Tablets Strengths and Packages.
| NDC Code | Tablet Strength | Package | |
|---|---|---|---|
| NDC 50458-577-60 | 2.5 mg | Bottle containing 60 tablets | |
| NDC 50458-577-18 | 2.5 mg | Bottle containing 180 tablets | |
| NDC 50458-577-10 | 2.5 mg | Blister package containing 100 tablets (10 blister cards containing 10 tablets each) | |
| NDC 50458-580-30 | 10 mg | Bottle containing 30 tablets | |
| NDC 50458-580-90 | 10 mg | Bottle containing 90 tablets | |
| NDC 50458-580-10 | 10 mg | Blister package containing 100 tablets (10 blister cards containing 10 tablets each) | |
| NDC 50458-578-30 | 15 mg | Bottle containing 30 tablets | |
| NDC 50458-578-90 | 15 mg | Bottle containing 90 tablets | |
| NDC 50458-578-10 | 15 mg | Blister package containing 100 tablets (10 blister cards containing 10 tablets each) | |
| NDC 50458-579-30 | 20 mg | Bottle containing 30 tablets | |
| NDC 50458-579-90 | 20 mg | Bottle containing 90 tablets | |
| NDC 50458-579-89 | 20 mg | Bulk bottle containing 1000 tablets | |
| NDC 50458-579-10 | 20 mg | Blister package containing 100 tablets (10 blister cards containing 10 tablets each) | |
| NDC 50458–584–51 | Starter Pack | Blister pack containing 51 tablets | |
| Abbreviations: NDC, National Drug Code | |||
XARELTO (rivaroxaban) for oral suspension is available in the strength and package listed below. See Table: XARELTO Oral Suspension Strength and Package
| NDC Code | Package |
|---|---|
| NDC 50458-575-01 | Supplied as white to off-white granules in an amber glass bottle containing 155 mg rivaroxaban packaged with two oral dosing syringes. After reconstitution with 150 mL of purified water, 1 mL of the suspension contains 1 mg rivaroxaban. |
| Abbreviations: NDC, National Drug Code | |
Discard reconstituted suspension after “Discard after” date written on the bottle.1
Storage of tablets, granules, and reconstituted suspension: Store at room temperature between 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F; see United States Pharmacopeia [USP] Controlled Room Temperature).1
Do not freeze the granules or reconstituted suspension.1
Keep out of the reach of children.1
TABLET AND PACKAGE ILLUSTRATIONS
Starter Pack Interior and Contents
LITERATURE SEARCH
References
| 1 | XARELTO (rivaroxaban) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf |
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