RIVAROXABAN
- Product NDC
- 68180-709
- 11-digit product format
- 681800709
- Labeler code
- 68180
- Product ID
- 68180-709_310f0bf6-9b0f-441b-afd7-b9a0f7905395
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RIVAROXABAN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA208555
- Marketing category
- ANDA
- Marketing start
- 2025-03-06
- 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
- 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 | 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 |
|---|
| 68180-709-06 | RIVAROXABAN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 14 |
| 68180-709-09 | RIVAROXABAN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-709 | RIVAROXABAN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 11 | Current NDC, 2 package rows | 20250309_702fed3e-ae25-49ba-98cc-562e0e244214.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-709-06 | 68180070906 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-709-06) | 2025-03-06 | No | No | Current |
| 68180-709-09 | 68180070909 | 90 TABLET, FILM COATED in 1 BOTTLE (68180-709-09) | 2025-03-06 | No | No | Current |