Home NDC 55154-3625 CELEBREX
Product NDC 55154-3625
11-digit product format 551543625
Labeler code 55154
Product ID 55154-3625_669e7793-d216-42ce-b8d4-616dc506d5c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Cardinal Health
Application NDA020998
Marketing category NDA
Marketing start 1998-10-02
Marketing end 0000-00-00
Substance CELECOXIB
Active strength 200 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 25 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55154-3625-7 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55154-3625-7 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55154-3625-7 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55154-3625-7 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55154-3625-7 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55154-3625-7 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55154-3625-7 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55154-3625-7 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55154-3625-7 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55154-3625-7 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55154-3625-7 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55154-3625-7 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020998-001 CELEBREX CELECOXIB 100MG CAPSULE / ORAL AB RLD 1998-12-31 N020998-002 CELEBREX CELECOXIB 200MG CAPSULE / ORAL AB RLD 1998-12-31 N020998-003 CELEBREX CELECOXIB 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 N020998-004 CELEBREX CELECOXIB 50MG CAPSULE / ORAL AB RLD 2006-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020998-001 CELEBREX 100MG CAPSULE / ORAL AB RLD 1998-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020998-002 CELEBREX 200MG CAPSULE / ORAL AB RLD 1998-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020998-003 CELEBREX 400MG CAPSULE / ORAL AB RLD, RS 2002-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020998-004 CELEBREX 50MG CAPSULE / ORAL AB RLD 2006-12-15 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Socrata Ingredients# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CELEBREX CELECOXIB Viatris Specialty LLC 2d6675e4-5859-4be2-8037-a20ce9f707aa 2024-11-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020998 application number: NDA020998