SEGLENTIS

Product NDC: 66869-564
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66869-564		D	Discontinued by firm	2026-10-15
excluded package	package	66869-564	66869-564-30	D	Discontinued by firm	2026-10-15
excluded package	package	66869-564	66869-564-35	D	Discontinued by firm	2026-10-15
excluded package	package	66869-564	66869-564-90	D	Discontinued by firm	2026-10-15

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66869-564-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66869-564-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66869-564-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66869-564-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66869-564-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66869-564-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66869-564-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66869-564-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66869-564-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66869-564-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66869-564-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66869-564-35	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66869-564-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66869-564-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66869-564-35	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66869-564-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66869-564-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66869-564-35	`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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	NP	2024-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	NP	2024-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	NP	2024-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213426-001	NP	2024-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213426-001	NP	2024-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213426-001	NP	2024-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213426-001	NP	2024-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213426-001	NP	2024-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213426-001	NP	2024-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213426-001	NP	2024-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213426-001	NP	2024-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213426-001	NP	2024-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213426-001	NP	2024-10-15	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213426-001	NP	2024-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213426-001	NP	2024-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213426-001	NP	2024-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213426-001	NP	2024-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213426-001	NP	2024-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213426-001	NP	2024-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213426-001	NP	2024-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213426-001	NP	2024-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213426-001	NP	2024-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213426-001	NP	2024-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213426-001	NP	2024-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213426-001	NP	2024-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213426-001	NP	2024-10-15	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66869-564-35	EA - Each	66869-564	06e25ef4-5392-47b4-9767-96af39547fed	1	2023-01-09
66869-564-90	EA - Each	66869-564	6b69462f-7c4c-48af-96d6-b3aaa74319a5	1	2022-03-09

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JCX84Q7J1L	CELECOXIB	169590-42-5	CELECOXIB
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66869-564-30	66869056430	1 BOTTLE, PLASTIC in 1 CARTON (66869-564-30) > 30 TABLET in 1 BOTTLE, PLASTIC		2022-01-01	0000-00-00	No	No	Current
66869-564-35	66869056435	35 TABLET in 1 BOTTLE, PLASTIC (66869-564-35)	35 tablet	2022-12-01	0000-00-00	No	No	Current
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