Rivaroxaban
- Product NDC
- 60505-6256
- 11-digit product format
- 605056256
- Labeler code
- 60505
- Product ID
- 60505-6256_0e1a0098-1b42-db14-8e0f-23c8ee1e35cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rivaroxaban
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA217810
- Marketing category
- ANDA
- Marketing start
- 2025-05-02
- Substance
- RIVAROXABAN
- Active strength
- 2.5 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
- Rivaroxaban
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RIVAROXABAN | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9NDF7JZ4M3 |
| Rxcui | 2059015 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-6256-5 | Rivaroxaban | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 60505-6256-6 | Rivaroxaban | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6256 | RIVAROXABAN TABLET, FILM COATED [APOTEX CORP.] | 1 | Current NDC, 2 package rows | 20250503_e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-6256-5 | 60505625605 | 500 TABLET, FILM COATED in 1 BOTTLE (60505-6256-5) | 2025-05-02 | No | No | Historical |
| 60505-6256-6 | 60505625606 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-6256-6) | 2025-05-02 | No | No | Historical |