RIVAROXABAN
- Product NDC
- 62332-346
- 11-digit product format
- 623320346
- Labeler code
- 62332
- Product ID
- 62332-346_43438909-74d8-4b11-b947-00d06de77c88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RIVAROXABAN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA210301
- Marketing category
- ANDA
- Marketing start
- 2025-05-14
- Substance
- RIVAROXABAN
- Active strength
- 10 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9NDF7JZ4M3 | RIVAROXABAN | 366789-02-8 | RIVAROXABAN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-346-10 | 62332034610 | 100 BLISTER PACK in 1 CARTON (62332-346-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2025-05-14 | No | No | Historical |
| 62332-346-30 | 62332034630 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-346-30) | | 2025-05-14 | No | No | Historical |
| 62332-346-90 | 62332034690 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-346-90) | | 2025-05-14 | No | No | Historical |
| 62332-346-91 | 62332034691 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-346-91) | | 2025-05-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| RIVAROXABAN | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 2025-10-17 | Human Prescription Drug Label | 7 |
| RIVAROXABAN | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 2025-06-27 | Human Prescription Drug Label | 6 |