rivaroxaban
- Product NDC
- 55488-0540
- 11-digit product format
- 554880540
- Labeler code
- 55488
- Product ID
- 55488-0540_8b1205ed-1f1c-4e13-8076-aefada9213ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rivaroxaban
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Changzhou Pharmaceutical Factory
- Application
- ANDA216995
- Marketing category
- ANDA
- Marketing start
- 2026-02-01
- Substance
- RIVAROXABAN
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9NDF7JZ4M3 |
| Rxcui | 1114198, 1232082, 1232086 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55488-0540-1 | rivaroxaban | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55488-0540-1 | 55488054001 | 30 TABLET, FILM COATED in 1 BOTTLE (55488-0540-1) | 2026-02-01 | No | No | Historical |