Home NDC 57894-070 Simponi
Product NDC 57894-070
11-digit product format 578940070
Labeler code 57894
Product ID 57894-070_02ee9cf4-c6d6-4239-854e-7c5976977456
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name golimumab
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Janssen Biotech, Inc.
Application BLA125289
Marketing category BLA
Marketing start 2009-04-25
Substance GOLIMUMAB
Active strength 50 mg/.5mL
Pharmacologic classes Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Simponi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GOLIMUMAB 50 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 91X1KLU43E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 848160 Internal RxNorm lookup 848164 Internal RxNorm lookup 1482813 Internal RxNorm lookup 1482814 Internal RxNorm lookup 1653142 Internal RxNorm lookup 1653144 Internal RxNorm lookup 1653165 Internal RxNorm lookup 1653166 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57894-070-01 Simponi 1 in 1 CARTON INJECTION, SOLUTION 1 42 57894-070-01 Simponi 0.5 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 0.5 42 57894-070-02 Simponi 0.5 mL in 1 SYRINGE INJECTION, SOLUTION 0.5 42 57894-070-02 Simponi 1 in 1 CARTON INJECTION, SOLUTION 1 42 57894-070-89 Simponi 1 in 1 CARTON INJECTION, SOLUTION 1 42 57894-070-89 Simponi 0.5 mL in 1 SYRINGE INJECTION, SOLUTION 0.5 42 57894-070-90 Simponi 1 in 1 CARTON INJECTION, SOLUTION 1 42 57894-070-90 Simponi 0.5 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 0.5 42
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded golimumab ACTIVE INGREDIENT 91X1KLU43E SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 18 golimumab ACTIVE MOIETY 91X1KLU43E SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 18 Histidine INACTIVE INGREDIENT 4QD397987E SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 18 Histidine Monohydrochloride Monohydrate INACTIVE INGREDIENT X573657P6P SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 18 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 18 sorbitol INACTIVE INGREDIENT 506T60A25R SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 18 water INACTIVE INGREDIENT 059QF0KO0R SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57894-070 SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] 36 Current NDC, Legacy NDC, 8 package rows 20250429_f86cb4a7-c358-4136-ae57-b32bda9bba00.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125289 Simponi golimumab 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57894-070-01 57894007001 1 SYRINGE, GLASS in 1 CARTON (57894-070-01) / .5 mL in 1 SYRINGE, GLASS 2009-04-25 0000-00-00 No No Current 57894-070-02 57894007002 1 SYRINGE in 1 CARTON (57894-070-02) / .5 mL in 1 SYRINGE 1 syringe 2009-04-25 0000-00-00 No No Current 57894-070-89 57894007089 1 SYRINGE in 1 CARTON (57894-070-89) / .5 mL in 1 SYRINGE 1 syringe 2009-04-25 0000-00-00 No No Current 57894-070-90 57894007090 1 SYRINGE, GLASS in 1 CARTON (57894-070-90) / .5 mL in 1 SYRINGE, GLASS 2009-04-25 0000-00-00 No No Current