rivaroxaban
- Product NDC
- 71921-405
- 11-digit product format
- 719210405
- Labeler code
- 71921
- Product ID
- 71921-405_f0ef9361-f06d-4028-97af-183b545f4aea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rivaroxaban
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC
- Application
- ANDA218445
- Marketing category
- ANDA
- Marketing start
- 2025-08-20
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- rivaroxaban
- Listing expiration
- 2026-12-31
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 |
|---|
| 71921-405-06 | rivaroxaban | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71921-405-21 | rivaroxaban | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71921-405-06 | 71921040506 | 60 TABLET in 1 BOTTLE (71921-405-06) | 60 tablet | 2025-08-20 | No | No | Historical |
| 71921-405-21 | 71921040521 | 180 TABLET in 1 BOTTLE (71921-405-21) | 180 tablet | 2025-08-20 | No | No | Historical |