simponi

Generic: golimumab

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

Drug Facts

Product Profile

Brand Name simponi
Generic Name golimumab
Labeler janssen biotech, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

golimumab 50 mg/.5mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-070
Product ID 57894-070_02ee9cf4-c6d6-4239-854e-7c5976977456
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125289
Listing Expiration 2027-12-31
Marketing Start 2009-04-25

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 57894070
Hyphenated Format 57894-070

Supplemental Identifiers

RxCUI
848160 848164 1482813 1482814 1653142 1653144 1653165 1653166
UNII
91X1KLU43E
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 simponi (source: ndc)
Generic Name golimumab (source: ndc)
Application Number BLA125289 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (57894-070-01) / .5 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE in 1 CARTON (57894-070-02) / .5 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (57894-070-89) / .5 mL in 1 SYRINGE
  • 1 SYRINGE, GLASS in 1 CARTON (57894-070-90) / .5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (4)

57894-070-01 1 SYRINGE, GLASS in 1 CARTON (57894-070-01) / .5 mL in 1 SYRINGE, GLASS 57894-070-02 1 SYRINGE in 1 CARTON (57894-070-02) / .5 mL in 1 SYRINGE 57894-070-89 1 SYRINGE in 1 CARTON (57894-070-89) / .5 mL in 1 SYRINGE 57894-070-90 1 SYRINGE, GLASS in 1 CARTON (57894-070-90) / .5 mL in 1 SYRINGE, GLASS

Ingredients (1)

golimumab (50 mg/.5mL)

Linked Drug Pages (1)

Simponi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "02ee9cf4-c6d6-4239-854e-7c5976977456", "openfda": {"nui": ["N0000175610", "N0000175451"], "unii": ["91X1KLU43E"], "rxcui": ["848160", "848164", "1482813", "1482814", "1653142", "1653144", "1653165", "1653166"], "spl_set_id": ["f86cb4a7-c358-4136-ae57-b32bda9bba00"], "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 SYRINGE, GLASS in 1 CARTON (57894-070-01)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "57894-070-01", "marketing_start_date": "20090425"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (57894-070-02)  / .5 mL in 1 SYRINGE", "package_ndc": "57894-070-02", "marketing_start_date": "20090425"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (57894-070-89)  / .5 mL in 1 SYRINGE", "package_ndc": "57894-070-89", "marketing_start_date": "20090425"}, {"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (57894-070-90)  / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "57894-070-90", "marketing_start_date": "20090425"}], "brand_name": "Simponi", "product_id": "57894-070_02ee9cf4-c6d6-4239-854e-7c5976977456", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "57894-070", "generic_name": "golimumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simponi", "active_ingredients": [{"name": "GOLIMUMAB", "strength": "50 mg/.5mL"}], "application_number": "BLA125289", "marketing_category": "BLA", "marketing_start_date": "20090425", "listing_expiration_date": "20271231"}