renflexis

Generic: infliximab

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name renflexis
Generic Name infliximab
Labeler organon llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

infliximab 100 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-162
Product ID 78206-162_ae5aa866-45c5-4dd8-ace4-cabe72994604
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761054
Listing Expiration 2026-12-31
Marketing Start 2017-04-21

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 78206162
Hyphenated Format 78206-162

Supplemental Identifiers

RxCUI
1927285 1927290
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 renflexis (source: ndc)
Generic Name infliximab (source: ndc)
Application Number BLA761054 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (78206-162-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99)
source: ndc

Packages (1)

78206-162-01 1 VIAL in 1 CARTON (78206-162-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99)

Ingredients (1)

infliximab (100 mg/1)

Linked Drug Pages (1)

Renflexis ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ae5aa866-45c5-4dd8-ace4-cabe72994604", "openfda": {"nui": ["N0000175610", "N0000175451"], "unii": ["B72HH48FLU"], "rxcui": ["1927285", "1927290"], "spl_set_id": ["dbf738c4-3fac-4422-a9d8-51d9c83a8789"], "pharm_class_epc": ["Tumor Necrosis Factor Blocker [EPC]"], "pharm_class_moa": ["Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (78206-162-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99)", "package_ndc": "78206-162-01", "marketing_start_date": "20210601"}], "brand_name": "Renflexis", "product_id": "78206-162_ae5aa866-45c5-4dd8-ace4-cabe72994604", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "78206-162", "generic_name": "infliximab", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Renflexis", "active_ingredients": [{"name": "INFLIXIMAB", "strength": "100 mg/1"}], "application_number": "BLA761054", "marketing_category": "BLA", "marketing_start_date": "20170421", "listing_expiration_date": "20261231"}