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 INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

infliximab-dyyb 120 mg/mL

Manufacturer
CELLTRION USA Inc.

Identifiers & Regulatory

Product NDC 72606-047
Product ID 72606-047_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

Pharmacologic Class

Classes
tumor necrosis factor blocker [epc] tumor necrosis factor receptor blocking activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72606047
Hyphenated Format 72606-047

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: ndc

Resolved Composition

Strengths
  • 120 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (72606-047-01) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

72606-047-01 1 SYRINGE in 1 CARTON (72606-047-01) / 1 mL in 1 SYRINGE

Ingredients (1)

infliximab-dyyb (120 mg/mL)

Linked Drug Pages (1)

ZYMFENTRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "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": true, "description": "1 SYRINGE in 1 CARTON (72606-047-01)  / 1 mL in 1 SYRINGE", "package_ndc": "72606-047-01", "marketing_start_date": "20240301"}], "brand_name": "ZYMFENTRA", "product_id": "72606-047_93e680bc-fd2e-4df7-9c72-70695026ad8d", "dosage_form": "INJECTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "72606-047", "generic_name": "infliximab-dyyb", "labeler_name": "CELLTRION USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYMFENTRA", "active_ingredients": [{"name": "INFLIXIMAB-DYYB", "strength": "120 mg/mL"}], "application_number": "BLA761358", "marketing_category": "BLA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}