Home NDC 0006-4305 Renflexis
Product NDC 0006-4305
11-digit product format 000064305
Labeler code 0006
Product ID 0006-4305_30c59fed-f54d-4d12-bf5f-495429b14dda
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name infliximab
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Merck Sharp & Dohme Corp.
Application BLA761054
Marketing category BLA
Marketing start 2017-07-01
Marketing end 0000-00-00
Substance INFLIXIMAB
Active strength 100 mg/1
Pharmacologic classes Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0006-4305-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0006-4305-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0006-4305-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0006-4305-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0006-4305-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0006-4305-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0006-4305-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0006-4305-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0006-4305-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0006-4305-02 2025-01-30 C162847 48780-1 f386c649-e6fb-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe 0006-4305-02 2023-02-03 C162847 48780-1 f386c649-e6fb-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe 0006-4305-02 2023-01-30 C162847 48780-1 f386c649-e6fb-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-4305-01 Renflexis 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 14 0006-4305-02 Renflexis 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-4305 RENFLEXIS (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] 14 Legacy NDC, 2 package rows 20230204_3827e1be-f328-45f7-b113-311b57039f8c.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761054 Renflexis infliximab-abda 351(k) Biosimilar Rx 2026-07-01
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 0006-4305-01 00006430501 1 in 1 VIAL Historical 0006-4305-02 00006430502 1 VIAL in 1 CARTON (0006-4305-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0006-4305-01) 1 vial 2017-07-01 0000-00-00 No No Current