Home NDC 43598-866-09 ELYXYB
Product NDC 43598-866
Requested package NDC 43598-866-09
11-digit product format 435980866
Labeler code 43598
Product ID 43598-866_a864ef99-fd9f-2b3d-2cb1-dd6f44f6af82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form SOLUTION
Route ORAL
Labeler Dr. Reddy
Application NDA212157
Marketing category NDA
Marketing start 2020-10-05
Marketing end 0000-00-00
Substance CELECOXIB
Active strength 25 mg/mL
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 18 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…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 Product TE source text 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# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-866-04 ELYXYB 4.8 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 4.8 1 43598-866-09 ELYXYB 9 in 1 CARTON SOLUTION 9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-866 ELYXYB (CELECOXIB) SOLUTION [DR. REDDY’S LABORATORIES, INC] 1 Legacy NDC, 2 package rows 20201005_34454fef-e029-513c-f843-21f5cd3362ab.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 Marketing start Marketing end Sample Exclude flag Status 43598-866-09 43598086609 9 BOTTLE, UNIT-DOSE in 1 CARTON (43598-866-09) > 4.8 mL in 1 BOTTLE, UNIT-DOSE (43598-866-04) 2020-10-05 0000-00-00 No No Current