Rivaroxaban
- Product NDC
- 59651-849
- 11-digit product format
- 596510849
- Labeler code
- 59651
- Product ID
- 59651-849_41ba542b-b8da-4a6e-a39e-284fd6314627
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rivaroxaban
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA208544
- Marketing category
- ANDA
- Marketing start
- 2025-04-10
- 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 |
|---|
| 59651-849-18 | Rivaroxaban | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 5 |
| 59651-849-60 | Rivaroxaban | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-849 | RIVAROXABAN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 2 package rows | 20250426_bcb0e6e7-3006-4d82-8009-c5fddbbfc80d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-849-18 | 59651084918 | 180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18) | 2025-04-10 | No | No | Historical |
| 59651-849-60 | 59651084960 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-849-60) | 2025-04-10 | No | No | Historical |