Imdelltra (Amg757) (tarlatamab-dlle) NDC 55513-077

NDC codes

FDA NDC Directory

Product NDC (as listed)55513-077Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55513-0077Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
55513-077-01	55513007701	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, Inc
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761344
Marketing start: May 16, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 55513-077_27ebb1b1-13da-4058-9e0b-65c04dd062feSPL ID 27ebb1b1-13da-4058-9e0b-65c04dd062feSPL set ID 1e7b6163-5d83-42ea-82c9-cf7620cdc782RxCUI 2682961, 2682967, 2682969, 2682971

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

N455513007701 followed by a unit qualifier and the quantity

Package 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

Current FDA label (SPL), effective Jun 23, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T- cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum - based chemotherapy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761344

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761344
Product	Strength	Form · route	Labeler	Product NDC
Imdelltra (Amg757)tarlatamab-dlle	—	Kit	Amgen, Inc	55513-059