ELYXYB - celecoxib

Product NDC: 59385-055
11-digit product format: 593850055
Labeler code: 59385
Product ID: 59385-055_942cdd49-03ae-42ee-a866-a2ab78873d38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: celecoxib
Dosage form: LIQUID
Route: ORAL
Labeler: BioDelivery Sciences International Inc
Application: NDA212157
Marketing category: NDA
Marketing start: 2022-01-01
Marketing end: 0000-00-00
Substance: CELECOXIB
Active strength: 120 mg/4.8mL
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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59385-055		I	Inactivated by FDA	2026-08-17
excluded package	package	59385-055	59385-055-06	I	Inactivated by FDA	2026-08-17
excluded package	package	59385-055	59385-055-22	I	Inactivated by FDA	2026-08-17

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59385-055-22	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59385-055-06	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59385-055-22	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59385-055-06	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59385-055-22	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59385-055-06	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59385-055-22	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59385-055-06	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59385-055-22	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59385-055-06	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59385-055-22	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59385-055-06	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59385-055-22	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59385-055-06	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59385-055-22	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59385-055-06	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59385-055-22	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59385-055-06	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N212157-001	ELYXYB	CELECOXIB	25MG/ML	SOLUTION / ORAL		RLD, RS	2020-05-05

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212157-001	10376527	2036-05-27	U-2718	Drug product	2020-05-11
N212157-001	10722456	2036-05-27	U-2718	Drug product	2020-08-14
N212157-001	10799517	2036-05-27	U-2718	Drug product	2020-10-28
N212157-001	9572819	2036-05-27	U-2718	Drug product	2020-05-11
N212157-001	9795620	2036-05-27	U-2718	Drug product	2020-05-11
N212157-001	9949990	2036-05-27	U-2718	Drug product	2020-05-11

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
2026-08-18 06:07:40	2026-07	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD	2020-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212157-001	ELYXYB	25MG/ML	SOLUTION / ORAL	RLD, RS	2020-05-05	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 227 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212157-001	10376527	2036-05-27	U-2718	Drug product	2020-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212157-001	10722456	2036-05-27	U-2718	Drug product	2020-08-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212157-001	10799517	2036-05-27	U-2718	Drug product	2020-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212157-001	9572819	2036-05-27	U-2718	Drug product	2020-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212157-001	9795620	2036-05-27	U-2718	Drug product	2020-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212157-001	9949990	2036-05-27	U-2718	Drug product	2020-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212157-001	10376527	2036-05-27	U-2718	Drug product	2020-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212157-001	10722456	2036-05-27	U-2718	Drug product	2020-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212157-001	10799517	2036-05-27	U-2718	Drug product	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212157-001	9572819	2036-05-27	U-2718	Drug product	2020-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212157-001	9795620	2036-05-27	U-2718	Drug product	2020-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212157-001	9949990	2036-05-27	U-2718	Drug product	2020-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212157-001	10376527	2036-05-27	U-2718	Drug product	2020-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212157-001	10722456	2036-05-27	U-2718	Drug product	2020-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212157-001	10799517	2036-05-27	U-2718	Drug product	2020-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212157-001	9572819	2036-05-27	U-2718	Drug product	2020-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212157-001	9795620	2036-05-27	U-2718	Drug product	2020-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212157-001	9949990	2036-05-27	U-2718	Drug product	2020-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212157-001	10376527	2036-05-27	U-2718	Drug product	2020-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212157-001	10722456	2036-05-27	U-2718	Drug product	2020-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212157-001	10799517	2036-05-27	U-2718	Drug product	2020-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212157-001	9572819	2036-05-27	U-2718	Drug product	2020-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212157-001	9795620	2036-05-27	U-2718	Drug product	2020-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212157-001	9949990	2036-05-27	U-2718	Drug product	2020-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212157-001	10376527	2036-05-27	U-2718	Drug product	2020-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212157-001	10722456	2036-05-27	U-2718	Drug product	2020-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212157-001	10799517	2036-05-27	U-2718	Drug product	2020-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212157-001	9572819	2036-05-27	U-2718	Drug product	2020-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212157-001	9795620	2036-05-27	U-2718	Drug product	2020-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212157-001	9949990	2036-05-27	U-2718	Drug product	2020-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212157-001	10376527	2036-05-27	U-2718	Drug product	2020-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212157-001	10722456	2036-05-27	U-2718	Drug product	2020-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212157-001	10799517	2036-05-27	U-2718	Drug product	2020-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212157-001	9572819	2036-05-27	U-2718	Drug product	2020-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212157-001	9795620	2036-05-27	U-2718	Drug product	2020-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212157-001	9949990	2036-05-27	U-2718	Drug product	2020-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212157-001	10376527	2036-05-27	U-2718	Drug product	2020-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212157-001	10722456	2036-05-27	U-2718	Drug product	2020-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212157-001	10799517	2036-05-27	U-2718	Drug product	2020-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212157-001	9572819	2036-05-27	U-2718	Drug product	2020-05-11	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212157-001	NP	2023-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212157-001	NP	2023-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212157-001	NP	2023-05-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212157-001	NP	2023-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212157-001	NP	2023-05-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212157-001	NP	2023-05-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212157-001	NP	2023-05-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212157-001	NP	2023-05-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212157-001	NP	2023-05-05	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N212157-001	NP	2023-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212157-001	NP	2023-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212157-001	NP	2023-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212157-001	NP	2023-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212157-001	NP	2023-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212157-001	NP	2023-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212157-001	NP	2023-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212157-001	NP	2023-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212157-001	NP	2023-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212157-001	NP	2023-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212157-001	NP	2023-05-05	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9a	Product name	1	20200925
827beb42-45f2-95b8-6aa3-f35174375422	Product name	9	20160429

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59385-055-06	2025-01-30	C162847	48780-1	2cef2736-9443-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ELYXYB safely and effectively. See full prescribing information for ELYXYB. ELYXYB (celecoxib) oral solution Initial U.S. Approval: 1998
59385-055-22	2025-01-30	C162847	48780-1	2cef2736-9443-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ELYXYB safely and effectively. See full prescribing information for ELYXYB. ELYXYB (celecoxib) oral solution Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59385-055-01	ELYXYB - celecoxib	4.8 mL in 1 BOTTLE	LIQUID	4.8	1
59385-055-02	ELYXYB - celecoxib	4.8 mL in 1 BOTTLE	LIQUID	4.8	1
59385-055-06	ELYXYB - celecoxib	6 in 1 CARTON	LIQUID	6	1
59385-055-22	ELYXYB - celecoxib	1 in 1 CARTON	LIQUID	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59385-055-01	ML - Milliliter	59385-055	95ea0cda-0b6e-4c36-82c5-bb49474c1aec	1	2021-12-08
59385-055-06	ML - Milliliter	59385-055	6d45fad7-3520-4faf-a2e3-3476d3733089	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59385-055	ELYXYB - CELECOXIB (CELECOXIB) LIQUID [BIODELIVERY SCIENCES INTERNATIONAL INC]	1	Legacy NDC, 4 package rows	20220101_a0bfcba9-0af6-4b45-80e3-c4c94065b777.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
ELYXYB - celecoxib	CELECOXIB	SCILEX PHARMACEUTICALS INC.	c8a5de07-9f27-4a54-a885-8089f0307bd7	2024-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212157 application number: NDA212157

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JCX84Q7J1L	CELECOXIB	169590-42-5	CELECOXIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2373454	celecoxib 120 MG in 4.8 mL Oral Solution	PSN	a0bfcba9-0af6-4b45-80e3-c4c94065b777	1
2373460	Elyxyb 120 MG in 4.8 mL Oral Solution	PSN	a0bfcba9-0af6-4b45-80e3-c4c94065b777	1
2373460	celecoxib 25 MG/ML Oral Solution [Elyxyb]	SBD	a0bfcba9-0af6-4b45-80e3-c4c94065b777	1
2373454	celecoxib 25 MG/ML Oral Solution	SCD	a0bfcba9-0af6-4b45-80e3-c4c94065b777	1
2373460	Elyxyb 120 MG per 4.8 mL Oral Solution	SY	a0bfcba9-0af6-4b45-80e3-c4c94065b777	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59385-055-01	59385005501	4.8 mL in 1 BOTTLE	4.8 ml					Historical
59385-055-02	59385005502	4.8 mL in 1 BOTTLE	4.8 ml					Historical
59385-055-06	59385005506	6 BOTTLE in 1 CARTON (59385-055-06) > 4.8 mL in 1 BOTTLE (59385-055-01)	6 bottle	2022-01-01	0000-00-00	No	No	Current
59385-055-22	59385005522	1 BOTTLE in 1 CARTON (59385-055-22) > 4.8 mL in 1 BOTTLE (59385-055-02)	1 bottle	2022-01-01	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELYXYB - celecoxib	BioDelivery Sciences International Inc	2021-10-01	HUMAN PRESCRIPTION DRUG LABEL	1