rivaroxaban granule
- Product NDC
- 70748-355
- 11-digit product format
- 707480355
- Labeler code
- 70748
- Product ID
- 70748-355_75d51b1e-1d97-40c7-854e-4736e335e048
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rivaroxaban granule
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA218195
- Marketing category
- ANDA
- Marketing start
- 2025-09-29
- Substance
- RIVAROXABAN
- Active strength
- 155 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 granule
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RIVAROXABAN | 155 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9NDF7JZ4M3 |
| Rxcui | 2588062 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70748-355-01 | rivaroxaban granule | 1 in 1 CARTON | FOR SUSPENSION | 1 | | 7 |
| 70748-355-01 | rivaroxaban granule | 1 in 1 BOTTLE | FOR SUSPENSION | 1 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70748-355-01 | 70748035501 | 1 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE | 1 bottle | 2025-09-29 | No | No | Current |