infliximab

Generic: infliximab

Labeler: janssen biotech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name infliximab
Generic Name infliximab
Labeler janssen biotech, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

infliximab 100 mg/10mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-160
Product ID 57894-160_3bfeaa57-8d95-4bc9-8bb5-274271688470
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103772
Listing Expiration 2027-12-31
Marketing Start 2021-10-05

Pharmacologic Class

Established (EPC)
tumor necrosis factor blocker [epc]
Mechanism of Action
tumor necrosis factor receptor blocking activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894160
Hyphenated Format 57894-160

Supplemental Identifiers

RxCUI
310994
UNII
B72HH48FLU
NUI
N0000175610 N0000175451

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 infliximab (source: ndc)
Generic Name infliximab (source: ndc)
Application Number BLA103772 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 BOX (57894-160-01) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

57894-160-01 1 VIAL, SINGLE-USE in 1 BOX (57894-160-01) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

infliximab (100 mg/10mL)

Linked Drug Pages (1)

INFLIXIMAB ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3bfeaa57-8d95-4bc9-8bb5-274271688470", "openfda": {"nui": ["N0000175610", "N0000175451"], "unii": ["B72HH48FLU"], "rxcui": ["310994"], "spl_set_id": ["b05c174f-832c-4321-b34f-2c4ad3742269"], "pharm_class_epc": ["Tumor Necrosis Factor Blocker [EPC]"], "pharm_class_moa": ["Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 BOX (57894-160-01)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "57894-160-01", "marketing_start_date": "20211005"}], "brand_name": "INFLIXIMAB", "product_id": "57894-160_3bfeaa57-8d95-4bc9-8bb5-274271688470", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "57894-160", "generic_name": "INFLIXIMAB", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INFLIXIMAB", "active_ingredients": [{"name": "INFLIXIMAB", "strength": "100 mg/10mL"}], "application_number": "BLA103772", "marketing_category": "BLA", "marketing_start_date": "20211005", "listing_expiration_date": "20271231"}