Prescription drug · BLA
Imdelltra (Amg757) (Tarlatamab-dlle) NDC 55513-077
Kit · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-077-01 | 5551300770155513007701 | 1 KIT in 1 PACKAGE (55513-077-01) * 10 mg in 1 VIAL (55513-069-01) * 7 mL in 1 VIAL (55513-068-01)Marketed from Jun 12, 2024 |
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)
- Imdelltra (Amg757)
- Generic name (nonproprietary)
- tarlatamab-dlle
- Dosage form
- Kit
- Labeler
- Amgen, IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761344
- Marketing start
- Listing expires
- Identifiers
- Product ID 55513-077_5e18b17d-1665-4984-a11b-0b55a82aa9fdSPL ID 5e18b17d-1665-4984-a11b-0b55a82aa9fd
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.
- NDC on a medical claim
N455513007701followed by a unit qualifier and the quantityPackage 55513-0077-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 55513-077
- What is NDC 55513-077?
- 55513-077 is the product NDC for Imdelltra (Amg757) (tarlatamab-dlle) kit, listed with the FDA by Amgen, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imdelltra (Amg757) (Tarlatamab-dlle).
- Who is the labeler?
- Amgen, Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imdelltra (Amg757)?
- 1 other product NDC are listed under this name. See all Imdelltra (Amg757) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imdelltra (Amg757) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imdelltra (Amg757)tarlatamab-dlle | — | Kit | Amgen, Inc | 55513-059 | 55513-0059-01 |
Other NDCs under BLA 761344
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 |
|---|---|---|---|---|
| Imdelltra (Amg757)tarlatamab-dlle | — | Kit | Amgen, Inc | 55513-059 |