zymfentra

Generic: infliximab-dyyb

Labeler: celltrion usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name zymfentra
Generic Name infliximab-dyyb
Labeler celltrion usa inc.
Dosage Form KIT
Manufacturer
CELLTRION USA Inc.

Identifiers & Regulatory

Product NDC 72606-025
Product ID 72606-025_93e680bc-fd2e-4df7-9c72-70695026ad8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761358
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72606025
Hyphenated Format 72606-025

Supplemental Identifiers

RxCUI
797544 2675742 2675749 2675753 2675757
UNII
B72HH48FLU

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 zymfentra (source: ndc)
Generic Name infliximab-dyyb (source: ndc)
Application Number BLA761358 (source: ndc)
Routes
subcutaneous
source: label

Resolved Composition

Strengths
  • 120 mg/ml
source: label
Packaging
  • 1 KIT in 1 CARTON (72606-025-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 2 KIT in 1 CARTON (72606-025-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 4 KIT in 1 CARTON (72606-025-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 6 KIT in 1 CARTON (72606-025-04) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 1 KIT in 1 CARTON (72606-025-05) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 2 KIT in 1 CARTON (72606-025-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 4 KIT in 1 CARTON (72606-025-07) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 6 KIT in 1 CARTON (72606-025-08) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 1 KIT in 1 CARTON (72606-025-09) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 2 KIT in 1 CARTON (72606-025-10) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 4 KIT in 1 CARTON (72606-025-11) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
  • 6 KIT in 1 CARTON (72606-025-12) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET
source: ndc

Packages (12)

72606-025-01 1 KIT in 1 CARTON (72606-025-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-02 2 KIT in 1 CARTON (72606-025-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-03 4 KIT in 1 CARTON (72606-025-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-04 6 KIT in 1 CARTON (72606-025-04) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-05 1 KIT in 1 CARTON (72606-025-05) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-06 2 KIT in 1 CARTON (72606-025-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-07 4 KIT in 1 CARTON (72606-025-07) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-08 6 KIT in 1 CARTON (72606-025-08) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-09 1 KIT in 1 CARTON (72606-025-09) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-10 2 KIT in 1 CARTON (72606-025-10) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-11 4 KIT in 1 CARTON (72606-025-11) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 72606-025-12 6 KIT in 1 CARTON (72606-025-12) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

ZYMFENTRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "93e680bc-fd2e-4df7-9c72-70695026ad8d", "openfda": {"unii": ["B72HH48FLU"], "rxcui": ["797544", "2675742", "2675749", "2675753", "2675757"], "spl_set_id": ["93a193ab-9f96-4da6-aa7c-31212e81879a"], "manufacturer_name": ["CELLTRION USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (72606-025-01)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-01", "marketing_start_date": "20240301"}, {"sample": false, "description": "2 KIT in 1 CARTON (72606-025-02)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-02", "marketing_start_date": "20240301"}, {"sample": false, "description": "4 KIT in 1 CARTON (72606-025-03)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-03", "marketing_start_date": "20240301"}, {"sample": false, "description": "6 KIT in 1 CARTON (72606-025-04)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-04", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 KIT in 1 CARTON (72606-025-05)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-05", "marketing_start_date": "20240301"}, {"sample": false, "description": "2 KIT in 1 CARTON (72606-025-06)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-06", "marketing_start_date": "20240301"}, {"sample": false, "description": "4 KIT in 1 CARTON (72606-025-07)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-07", "marketing_start_date": "20240301"}, {"sample": false, "description": "6 KIT in 1 CARTON (72606-025-08)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-08", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 KIT in 1 CARTON (72606-025-09)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-09", "marketing_start_date": "20240301"}, {"sample": false, "description": "2 KIT in 1 CARTON (72606-025-10)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-10", "marketing_start_date": "20240301"}, {"sample": false, "description": "4 KIT in 1 CARTON (72606-025-11)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-11", "marketing_start_date": "20240301"}, {"sample": false, "description": "6 KIT in 1 CARTON (72606-025-12)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE *  1 mL in 1 PACKET", "package_ndc": "72606-025-12", "marketing_start_date": "20240301"}], "brand_name": "ZYMFENTRA", "product_id": "72606-025_93e680bc-fd2e-4df7-9c72-70695026ad8d", "dosage_form": "KIT", "product_ndc": "72606-025", "generic_name": "infliximab-dyyb", "labeler_name": "CELLTRION USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYMFENTRA", "application_number": "BLA761358", "marketing_category": "BLA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}