NDC 50458-578 – Xarelto
Rivaroxaban 15 mg/1 · Tablet, Film Coated · Oral
Product NDC50458-578
Product details
- Brand name
- Xarelto
- Generic name
- Rivaroxaban
- Labeler
- Janssen Pharmaceuticals, Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- NDA · NDA022406
- Marketed since
- November 4, 2011
- Listing expires
- December 31, 2027
- Pharmacologic class
- Factor Xa Inhibitor
Active ingredients
- Rivaroxaban 15 mg/1
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 50458-578-07 sample | 7 TABLET, FILM COATED in 1 BOTTLE (50458-578-07) | Sep 20, 2016 |
| 50458-578-10 | 10 BLISTER PACK in 1 CARTON (50458-578-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (50458-578-01) | Nov 4, 2011 |
| 50458-578-30 | 30 TABLET, FILM COATED in 1 BOTTLE (50458-578-30) | Nov 4, 2011 |
| 50458-578-90 | 90 TABLET, FILM COATED in 1 BOTTLE (50458-578-90) | Nov 4, 2011 |
Recalls mentioning this NDC
- D-0006-2015 Oct 15, 2014 · Class II
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
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