IMJUDO
- Product NDC
- 0310-4505
- 11-digit product format
- 003104505
- Labeler code
- 0310
- Product ID
- 0310-4505_390ff583-8e40-4690-ac4c-b4eaef2229d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tremelimumab
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- BLA761289
- Marketing category
- BLA
- Marketing start
- 2022-10-21
- Substance
- TREMELIMUMAB
- Active strength
- 25 mg/1.25mL
- Pharmacologic classes
- CTLA-4-directed Antibody Interactions [MoA], CTLA-4-directed Blocking Antibody [EPC], Increased T Lymphocyte Activation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IMJUDO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TREMELIMUMAB | 25 mg/1.25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QEN1X95CIX |
| Rxcui | 2619317, 2619323, 2619325, 2619326 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-4505-25 | IMJUDO | 1.25 mL in 1 VIAL | INJECTION, SOLUTION | 1.25 | | 14 |
| 0310-4505-25 | IMJUDO | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-4505 | IMJUDO (TREMELIMUMAB) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240802_6690679c-be2f-4588-a2e4-89fff74dd6be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-4505-25 | 00310450525 | 1 VIAL in 1 CARTON (0310-4505-25) / 1.25 mL in 1 VIAL | 1 vial | 2022-10-21 | 0000-00-00 | No | No | Current |