Rivaroxaban
- Product NDC
- 76282-774
- 11-digit product format
- 762820774
- Labeler code
- 76282
- Product ID
- 76282-774_fcd1f593-213c-490f-b0d1-75b2d7817582
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rivaroxaban
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Exelan pharmaceuticals,Inc
- Application
- ANDA218117
- Marketing category
- ANDA
- Marketing start
- 2025-08-04
- 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 |
|---|
| 76282-774-18 | Rivaroxaban | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
| 76282-774-60 | Rivaroxaban | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76282-774-18 | 76282077418 | 180 TABLET, FILM COATED in 1 BOTTLE (76282-774-18) | 2025-08-04 | No | No | Current |
| 76282-774-60 | 76282077460 | 60 TABLET, FILM COATED in 1 BOTTLE (76282-774-60) | 2025-08-04 | No | No | Current |