Home NDC 59746-562 Celecoxib
Product NDC 59746-562
11-digit product format 597460562
Labeler code 59746
Product ID 59746-562_c0ee4996-6a07-4e2e-aa45-54ebe2e5f5fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Jubilant Cadista Pharmaceuticals Inc.
Application ANDA207061
Marketing category ANDA
Marketing start 2017-04-04
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 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 2 · 75 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 A207061-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 A207061-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 A207061-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 A207061-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL 2017-04-04
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 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207061-001 CELECOXIB 50MG CAPSULE / ORAL 2017-04-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207061-002 CELECOXIB 100MG CAPSULE / ORAL 2017-04-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207061-003 CELECOXIB 200MG CAPSULE / ORAL 2017-04-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207061-004 CELECOXIB 400MG CAPSULE / ORAL 2017-04-04 d06236e962d9…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59746-562-01 2026-01-05 These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998 59746-562-05 2026-01-05 These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998 59746-562-10 2026-01-05 These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998 59746-562-30 2026-01-05 These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998 59746-562-01 2023-01-30 These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998 59746-562-05 2023-01-30 These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998 59746-562-10 2023-01-30 These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998 59746-562-30 2023-01-30 These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-562 CELECOXIB (CELECOXIB) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.] 8 Legacy NDC 20210403_27d813ea-7798-09cb-734b-b970d7248f1f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59746-562-01 59746056201 100 CAPSULE in 1 BOTTLE (59746-562-01) 100 capsule 2017-04-04 0000-00-00 No No Current 59746-562-05 59746056205 500 CAPSULE in 1 BOTTLE (59746-562-05) 500 capsule 2017-04-04 0000-00-00 No No Current 59746-562-10 59746056210 1000 CAPSULE in 1 BOTTLE (59746-562-10) 1000 capsule 2017-04-04 0000-00-00 No No Current 59746-562-30 59746056230 30 CAPSULE in 1 BOTTLE (59746-562-30) 30 capsule 2017-04-04 0000-00-00 No No Current