Truxima
- Product NDC
- 63459-103
- 11-digit product format
- 634590103
- Labeler code
- 63459
- Product ID
- 63459-103_de5d8106-44b8-4510-9129-f6a163c5231e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rituximab-abbs
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Cephalon, Inc.
- Application
- BLA761088
- Marketing category
- BLA
- Marketing start
- 2020-05-04
- Substance
- RITUXIMAB
- Active strength
- 10 mg/mL
- Pharmacologic classes
- CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Truxima
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RITUXIMAB | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4F4X42SYQ6 |
| Rxcui | 2105826, 2105831, 2105834, 2105835 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63459-103-10 | Truxima | 10 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 10 | | 15 |
| 63459-103-10 | Truxima | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63459-103 | TRUXIMA (RITUXIMAB-ABBS) INJECTION, SOLUTION [CEPHALON, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241222_9af3ddc7-4217-417a-ac89-8704edc5bc44.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63459-103-10 | 63459010310 | 1 VIAL, SINGLE-USE in 1 CARTON (63459-103-10) / 10 mL in 1 VIAL, SINGLE-USE | 2020-05-04 | 0000-00-00 | No | No | Current |