Home NDC 69557-333-02 ELYXYB - celecoxib
Product NDC 69557-333
Requested package NDC 69557-333-02
11-digit product format 695570333
Labeler code 69557
Product ID 69557-333_ad5c6af3-1790-4a13-b4e5-6e3af543b2a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name celecoxib
Dosage form LIQUID
Route ORAL
Labeler SCILEX PHARMACEUTICALS INC.
Application NDA212157
Marketing category NDA
Marketing start 2023-11-27
Substance CELECOXIB
Active strength 120 mg/4.8mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N212157-001 ELYXYB 25MG/ML SOLUTION / ORAL RLD, RS 2020-05-05 84e616aacf4f…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 · 233 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N212157-001 10376527 2036-05-27 U-2718 Drug product 2020-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212157-001 10722456 2036-05-27 U-2718 Drug product 2020-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212157-001 10799517 2036-05-27 U-2718 Drug product 2020-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212157-001 9572819 2036-05-27 U-2718 Drug product 2020-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212157-001 9795620 2036-05-27 U-2718 Drug product 2020-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212157-001 9949990 2036-05-27 U-2718 Drug product 2020-05-11 84e616aacf4f…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…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ELYXYB - celecoxib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CELECOXIB 120 mg/4.8mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JCX84Q7J1L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2373454 Internal RxNorm lookup 2373460 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69557-333-01 ELYXYB - celecoxib 6 in 1 CARTON LIQUID 6 3 69557-333-01 ELYXYB - celecoxib 4.8 mL in 1 BOTTLE LIQUID 4.8 3 69557-333-02 ELYXYB - celecoxib 1 in 1 CARTON LIQUID 1 3 69557-333-02 ELYXYB - celecoxib 4.8 mL in 1 BOTTLE LIQUID 4.8 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69557-333 ELYXYB - CELECOXIB (CELECOXIB) LIQUID [SCILEX PHARMACEUTICALS INC.] 3 Current NDC, 4 package rows 20241206_c8a5de07-9f27-4a54-a885-8089f0307bd7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69557-333-02 69557033302 1 BOTTLE in 1 CARTON (69557-333-02) / 4.8 mL in 1 BOTTLE 1 bottle 2023-11-27 Yes No Current