RIVAROXABAN
- Product NDC
- 46708-347
- 11-digit product format
- 467080347
- Labeler code
- 46708
- Product ID
- 46708-347_4b61dc52-0593-4ef0-8246-a82ff6972842
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RIVAROXABAN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA210301
- Marketing category
- ANDA
- Marketing start
- 2025-05-14
- Substance
- RIVAROXABAN
- Active strength
- 15 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 | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9NDF7JZ4M3 |
| Rxcui | 1114198, 1232082, 1232086, 1549682, 2059015 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-347-10 | RIVAROXABAN | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
| 46708-347-10 | RIVAROXABAN | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 2 |
| 46708-347-30 | RIVAROXABAN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 46708-347-90 | RIVAROXABAN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 46708-347-91 | RIVAROXABAN | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-347 | RIVAROXABAN TABLET, FILM COATED RIVAROXABAN KIT [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 5 package rows | 20250523_5524f30f-789d-4f5c-8f7c-d03a475b6d34.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-347-10 | 46708034710 | 100 BLISTER PACK in 1 CARTON (46708-347-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2025-05-21 | No | No | Current |
| 46708-347-30 | 46708034730 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-347-30) | | 2025-05-14 | No | No | Current |
| 46708-347-90 | 46708034790 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-347-90) | | 2025-05-14 | No | No | Current |
| 46708-347-91 | 46708034791 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-347-91) | | 2025-05-14 | No | No | Current |