Home NDC 63629-3021 CELEBREX
Product NDC 63629-3021
11-digit product format 636293021
Labeler code 63629
Product ID 63629-3021_22d6020b-a76e-5068-e98c-299310df2898
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA020998
Marketing category NDA
Marketing start 1998-10-02
Marketing end 0000-00-00
Substance CELECOXIB
Active strength 200 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 3 · 143 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-3021-0 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-1 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-2 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-3 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-4 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-5 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-6 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-7 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-8 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-9 2020-10-16 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-0 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-1 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-2 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-3 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-4 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-5 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-6 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-7 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-8 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 63629-3021-9 2020-01-31 These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-3021-0 63629302100 28 CAPSULE in 1 BOTTLE (63629-3021-0) 28 capsule 2010-03-04 0000-00-00 No No Current 63629-3021-1 63629302101 30 CAPSULE in 1 BOTTLE (63629-3021-1) 30 capsule 2005-12-29 0000-00-00 No No Current 63629-3021-2 63629302102 20 CAPSULE in 1 BOTTLE (63629-3021-2) 20 capsule 2008-10-24 0000-00-00 No No Current 63629-3021-3 63629302103 90 CAPSULE in 1 BOTTLE (63629-3021-3) 90 capsule 2012-12-13 0000-00-00 No No Current 63629-3021-4 63629302104 60 CAPSULE in 1 BOTTLE (63629-3021-4) 60 capsule 2008-10-08 0000-00-00 No No Current 63629-3021-5 63629302105 120 CAPSULE in 1 BOTTLE (63629-3021-5) 120 capsule 2011-07-06 0000-00-00 No No Current 63629-3021-6 63629302106 15 CAPSULE in 1 BOTTLE (63629-3021-6) 15 capsule 2022-02-08 0000-00-00 No No Current 63629-3021-7 63629302107 6 CAPSULE in 1 BOTTLE (63629-3021-7) 6 capsule 2009-05-11 0000-00-00 No No Current 63629-3021-8 63629302108 14 CAPSULE in 1 BOTTLE (63629-3021-8) 14 capsule 2010-02-11 0000-00-00 No No Current 63629-3021-9 63629302109 56 CAPSULE in 1 BOTTLE (63629-3021-9) 56 capsule 2010-03-02 0000-00-00 No No Current