imdelltra (amg757)

Generic: tarlatamab-dlle

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name imdelltra (amg757)
Generic Name tarlatamab-dlle
Labeler amgen, inc
Dosage Form KIT
Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-077
Product ID 55513-077_2e2c9381-efd5-4804-aa85-cff5ee5d10ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761344
Listing Expiration 2026-12-31
Marketing Start 2024-05-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513077
Hyphenated Format 55513-077

Supplemental Identifiers

RxCUI
2682961 2682967 2682969 2682971

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imdelltra (amg757) (source: ndc)
Generic Name tarlatamab-dlle (source: ndc)
Application Number BLA761344 (source: ndc)

Resolved Composition

Strengths
  • 1 mg
  • 10 mg
  • 7 ml
source: label
Packaging
  • 1 KIT in 1 PACKAGE (55513-077-01) * 10 mg in 1 VIAL (55513-069-01) * 7 mL in 1 VIAL (55513-068-01)
source: ndc

Packages (1)

55513-077-01 1 KIT in 1 PACKAGE (55513-077-01) * 10 mg in 1 VIAL (55513-069-01) * 7 mL in 1 VIAL (55513-068-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

IMDELLTRA (AMG757) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "2e2c9381-efd5-4804-aa85-cff5ee5d10ec", "openfda": {"rxcui": ["2682961", "2682967", "2682969", "2682971"], "spl_set_id": ["1e7b6163-5d83-42ea-82c9-cf7620cdc782"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 PACKAGE (55513-077-01)  *  10 mg in 1 VIAL (55513-069-01)  *  7 mL in 1 VIAL (55513-068-01)", "package_ndc": "55513-077-01", "marketing_start_date": "20240612"}], "brand_name": "IMDELLTRA (AMG757)", "product_id": "55513-077_2e2c9381-efd5-4804-aa85-cff5ee5d10ec", "dosage_form": "KIT", "product_ndc": "55513-077", "generic_name": "Tarlatamab-dlle", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMDELLTRA (AMG757)", "application_number": "BLA761344", "marketing_category": "BLA", "marketing_start_date": "20240516", "listing_expiration_date": "20261231"}