Xarelto
- Product NDC
- 55154-1424
- 11-digit product format
- 551541424
- Labeler code
- 55154
- Product ID
- 55154-1424_fcb2aab9-1150-4d49-baf7-d03e0551d3c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rivaroxaban
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- NDA022406
- Marketing category
- NDA
- Marketing start
- 2011-11-04
- Substance
- RIVAROXABAN
- Active strength
- 15 mg/1
- Pharmacologic classes
- Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xarelto
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RIVAROXABAN | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9NDF7JZ4M3 |
| Rxcui | 1114198, 1114202, 1232082, 1232084, 1232086, 1232088 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-1424-8 | Xarelto | 2070 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 2070 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| rivaroxaban | ACTIVE INGREDIENT | 9NDF7JZ4M3 | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| rivaroxaban | ACTIVE MOIETY | 9NDF7JZ4M3 | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| polyethylene glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-1424 | XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 25 | Current NDC, Legacy NDC, 1 package rows | 20241122_d0e105f6-28f3-45ee-83bd-7d458835242b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-1424-8 | 55154142408 | 2070 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-1424-8) | 2011-11-04 | 0000-00-00 | No | No | Current |