Home NDC 66869-564-90 SEGLENTIS
Product NDC 66869-564
Requested package NDC 66869-564-90
11-digit product format 668690564
Labeler code 66869
Product ID 66869-564_d4abea2e-4722-4fcc-af04-99e2327777e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name celecoxib and tramadol hydrochloride
Dosage form TABLET
Route ORAL
Labeler Kowa Pharmaceuticals America, Inc.
Application NDA213426
Marketing category NDA
Marketing start 2022-01-01
Marketing end 0000-00-00
Substance CELECOXIB; TRAMADOL HYDROCHLORIDE
Active strength 56 mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC]
DEA schedule CIV
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 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213426-001 SEGLENTIS CELECOXIB; TRAMADOL HYDROCHLORIDE 56MG;44MG TABLET / ORAL RLD 2021-10-15
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213426-001 10238668 2030-04-19 U-3244 Drug substance, Drug product 2021-11-12 N213426-001 10245276 2030-04-19 Drug substance, Drug product 2021-11-12 N213426-001 10548909 2030-04-19 U-3244 2021-11-12 N213426-001 11478488 2030-04-19 U-3244 2022-11-07 N213426-001 8598152 2030-04-19 Drug substance, Drug product 2021-11-12 N213426-001 9012440 2030-04-19 Drug substance, Drug product 2021-11-12 N213426-001 8846744 2031-06-03 Drug product 2021-11-12
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.
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 2026-10-15 13:18:30 2026-09 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD, RS 2021-10-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213426-001 SEGLENTIS 56MG;44MG TABLET / ORAL RLD 2021-10-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 244 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N213426-001 10238668 2030-04-19 U-3244 Drug substance, Drug product 2021-11-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213426-001 10245276 2030-04-19 Drug substance, Drug product 2021-11-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213426-001 10548909 2030-04-19 U-3244 2021-11-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213426-001 11478488 2030-04-19 U-3244 2022-11-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213426-001 8598152 2030-04-19 Drug substance, Drug product 2021-11-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213426-001 9012440 2030-04-19 Drug substance, Drug product 2021-11-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213426-001 8846744 2031-06-03 Drug product 2021-11-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213426-001 10238668 2030-04-19 U-3244 Drug substance, Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213426-001 10245276 2030-04-19 Drug substance, Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213426-001 10548909 2030-04-19 U-3244 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213426-001 11478488 2030-04-19 U-3244 2022-11-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213426-001 8598152 2030-04-19 Drug substance, Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213426-001 9012440 2030-04-19 Drug substance, Drug product 2021-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213426-001 8846744 2031-06-03 Drug product 2021-11-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213426-001 10238668 2030-04-19 U-3244 Drug substance, Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213426-001 10245276 2030-04-19 Drug substance, Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213426-001 10548909 2030-04-19 U-3244 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213426-001 11478488 2030-04-19 U-3244 2022-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213426-001 8598152 2030-04-19 Drug substance, Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213426-001 9012440 2030-04-19 Drug substance, Drug product 2021-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213426-001 8846744 2031-06-03 Drug product 2021-11-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213426-001 10238668 2030-04-19 U-3244 Drug substance, Drug product 2021-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213426-001 10245276 2030-04-19 Drug substance, Drug product 2021-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213426-001 10548909 2030-04-19 U-3244 2021-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213426-001 11478488 2030-04-19 U-3244 2022-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213426-001 8598152 2030-04-19 Drug substance, Drug product 2021-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213426-001 9012440 2030-04-19 Drug substance, Drug product 2021-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213426-001 8846744 2031-06-03 Drug product 2021-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213426-001 10238668 2030-04-19 U-3244 Drug substance, Drug product 2021-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213426-001 10245276 2030-04-19 Drug substance, Drug product 2021-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213426-001 10548909 2030-04-19 U-3244 2021-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213426-001 11478488 2030-04-19 U-3244 2022-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213426-001 8598152 2030-04-19 Drug substance, Drug product 2021-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213426-001 9012440 2030-04-19 Drug substance, Drug product 2021-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213426-001 8846744 2031-06-03 Drug product 2021-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213426-001 10238668 2030-04-19 U-3244 Drug substance, Drug product 2021-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213426-001 10245276 2030-04-19 Drug substance, Drug product 2021-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213426-001 10548909 2030-04-19 U-3244 2021-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213426-001 11478488 2030-04-19 U-3244 2022-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213426-001 8598152 2030-04-19 Drug substance, Drug product 2021-11-12 6a471c1ec25d…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 66869-564-90 66869056490 1 BOTTLE, PLASTIC in 1 CARTON (66869-564-90) > 90 TABLET in 1 BOTTLE, PLASTIC 2022-01-01 0000-00-00 No No Current