Home NDC 59762-1516 Celecoxib
Product NDC 59762-1516
11-digit product format 597621516
Labeler code 59762
Product ID 59762-1516_094be167-4b68-4dd0-b996-8802dadf1fc9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Greenstone LLC
Application NDA020998
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-12-10
Marketing end 0000-00-00
Substance CELECOXIB
Active strength 100 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-1516 CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.] 11 Legacy NDC 20250502_12c2b345-bf1c-4661-85a8-257c4af2bda5.zip
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 59762-1516-1 59762151601 100 CAPSULE in 1 BOTTLE (59762-1516-1) 100 capsule 2014-12-10 0000-00-00 No No Current 59762-1516-3 59762151603 500 CAPSULE in 1 BOTTLE (59762-1516-3) 500 capsule 2014-12-10 0000-00-00 No No Current