Adbry
- Product NDC
- 50222-350
- 11-digit product format
- 502220350
- Labeler code
- 50222
- Product ID
- 50222-350_8abedac8-f75e-42a0-8591-10fabcf41fb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tralokinumab-ldrm
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- LEO Pharma Inc.
- Application
- BLA761180
- Marketing category
- BLA
- Marketing start
- 2024-07-01
- Substance
- TRALOKINUMAB
- Active strength
- 300 mg/2mL
- Pharmacologic classes
- Interleukin-13 Antagonist [EPC], Interleukin-13 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Adbry
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRALOKINUMAB | 300 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GK1LYB375A |
| Rxcui | 2589378, 2589384, 2686061, 2686065 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50222-350-00 | Adbry | 2 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 2 | | 15 |
| 50222-350-01 | Adbry | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 15 |
| 50222-350-02 | Adbry | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 15 |
| 50222-350-90 | Adbry | 2 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 2 | | 15 |
| 50222-350-91 | Adbry | 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 |
|---|
| 50222-350 | ADBRY (TRALOKINUMAB-LDRM) INJECTION, SOLUTION [LEO PHARMA INC.] | 14 | Current NDC, 5 package rows | 20240701_d8020b69-3001-44e2-9b5d-5f93d9aaf6e1.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 |
|---|
| 50222-350-00 | 50222035000 | 2 mL in 1 SYRINGE, GLASS | 2 ml | | | | Historical |
| 50222-350-01 | 50222035001 | 1 SYRINGE, GLASS in 1 CARTON (50222-350-01) / 2 mL in 1 SYRINGE, GLASS (50222-350-00) | | 2024-07-01 | No | No | Current |
| 50222-350-02 | 50222035002 | 2 SYRINGE, GLASS in 1 CARTON (50222-350-02) / 2 mL in 1 SYRINGE, GLASS (50222-350-00) | | 2024-07-01 | No | No | Current |
| 50222-350-90 | 50222035090 | 2 mL in 1 SYRINGE, GLASS | 2 ml | | | | Historical |
| 50222-350-91 | 50222035091 | 1 SYRINGE, GLASS in 1 CARTON (50222-350-91) / 2 mL in 1 SYRINGE, GLASS (50222-350-90) | | 2024-07-01 | Yes | No | Current |