Prescription drug · BLA
Adbry (Tralokinumab-ldrm) NDC 50222-346
Tralokinumab 150 mg/mL · Injection, Solution · Subcutaneous · LEO Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50222-346-02 | 50222034602 | 2 SYRINGE, GLASS in 1 CARTON (50222-346-02) / 1 mL in 1 SYRINGE, GLASS (50222-346-01)Marketed from Jan 2, 2022 | |
| 50222-346-04 | 50222034604 | 2 CARTON in 1 CARTON (50222-346-04) / 2 SYRINGE, GLASS in 1 CARTON (50222-346-22) / 1 mL in 1 SYRINGE, GLASS (50222-346-01)Marketed from Jan 2, 2022 | |
| 50222-346-92 | 50222034692 | 2 SYRINGE, GLASS in 1 CARTON (50222-346-92) / 1 mL in 1 SYRINGE, GLASS (50222-346-91)Marketed from Jan 2, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Adbry
- Generic name (nonproprietary)
- tralokinumab-ldrm
- Active ingredients
- Tralokinumab — 150 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- LEO Pharma Inc.NDC labeler code 50222
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761180
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-13 Antagonists (Mechanism)
- Identifiers
- Product ID 50222-346_8abedac8-f75e-42a0-8591-10fabcf41fb5SPL ID 8abedac8-f75e-42a0-8591-10fabcf41fb5SPL set ID d8020b69-3001-44e2-9b5d-5f93d9aaf6e1RxCUI 2589378, 2589384, 2686061, 2686065UNII GK1LYB375A
- Pharmacologic class
- Interleukin-13 Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450222034602followed by a unit qualifier and the quantityPackage 50222-0346-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ADBRY is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50222-346
- What is NDC 50222-346?
- 50222-346 is the product NDC for Adbry (tralokinumab-ldrm), Tralokinumab 150 mg/mL injection, solution, listed with the FDA by LEO Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adbry (Tralokinumab-ldrm).
- What is the active ingredient?
- Tralokinumab.
- Who is the labeler?
- LEO Pharma Inc., NDC labeler code 50222. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adbry?
- 1 other product NDC are listed under this name. See all Adbry NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adbry products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adbrytralokinumab-ldrm | Tralokinumab 300 mg/2mL | Injection, SolutionSubcutaneous | LEO Pharma Inc. | 50222-350 | 50222-0350-0150222-0350-0250222-0350-91 |
Other NDCs under BLA 761180
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Adbrytralokinumab-ldrm | Tralokinumab 300 mg/2mL | Injection, SolutionSubcutaneous | LEO Pharma Inc. | 50222-350 |