Home NDC 69344-204 Zorvolex
Product NDC 69344-204
11-digit product format 693440204
Labeler code 69344
Product ID 69344-204_f5e319f9-9eeb-4bc5-9e53-985549d08d44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac
Dosage form CAPSULE
Route ORAL
Labeler Zyla Life Sciences US Inc.
Application NDA204592
Marketing category NDA
Marketing start 2019-02-04
Marketing end 0000-00-00
Substance DICLOFENAC
Active strength 35 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],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 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 69344-204-29 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 69344-204-29 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 69344-204-29 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 69344-204-29 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 69344-204-29 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 69344-204-29 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69344-204-29 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69344-204-29 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69344-204-29 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69344-204-29 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69344-204-29 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69344-204-29 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204592-001 ZORVOLEX DICLOFENAC 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 N204592-002 ZORVOLEX DICLOFENAC 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204592-001 8679544 2030-04-23 Drug product 2014-03-25 N204592-001 8999387 2030-04-23 U-55 2015-04-07 N204592-001 9017721 2030-04-23 Drug product 2015-04-29 N204592-001 9173854 2030-04-23 Drug product 2015-11-05 N204592-001 9180095 2030-04-23 U-55 2015-11-12 N204592-001 9180096 2030-04-23 Drug product 2015-11-12 N204592-001 9186328 2030-04-23 U-55 2015-11-19 N204592-002 8679544 2030-04-23 Drug product 2014-03-25 N204592-002 8999387 2030-04-23 U-55 2015-04-07 N204592-002 9017721 2030-04-23 Drug product 2015-04-29 N204592-002 9173854 2030-04-23 Drug product 2015-11-05 N204592-002 9180095 2030-04-23 U-55 2015-11-12 N204592-002 9180096 2030-04-23 Drug product 2015-11-12 N204592-002 9186328 2030-04-23 U-55 2015-11-19
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.
Product history page 1 of 3 · 84 observed 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 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-002 ZORVOLEX 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-002 ZORVOLEX 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-002 ZORVOLEX 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204592-002 ZORVOLEX 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204592-002 ZORVOLEX 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204592-002 ZORVOLEX 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204592-002 ZORVOLEX 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD 2013-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD 2013-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD 2013-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD 2013-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD 2013-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD 2013-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD 2013-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204592-001 ZORVOLEX 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD 2013-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204592-001 ZORVOLEX 18MG CAPSULE / ORAL RLD 2013-10-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD, RS 2013-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204592-001 ZORVOLEX 18MG CAPSULE / ORAL RLD 2013-10-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD, RS 2013-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204592-001 ZORVOLEX 18MG CAPSULE / ORAL RLD 2013-10-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD, RS 2013-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204592-001 ZORVOLEX 18MG CAPSULE / ORAL RLD 2013-10-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD, RS 2013-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204592-001 ZORVOLEX 18MG CAPSULE / ORAL RLD 2013-10-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204592-002 ZORVOLEX 35MG CAPSULE / ORAL RLD, RS 2013-10-18 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 15 · 588 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 N204592-001 8679544 2030-04-23 Drug product 2014-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-001 8999387 2030-04-23 U-55 2015-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-001 9017721 2030-04-23 Drug product 2015-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-001 9173854 2030-04-23 Drug product 2015-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-001 9180095 2030-04-23 U-55 2015-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-001 9180096 2030-04-23 Drug product 2015-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-001 9186328 2030-04-23 U-55 2015-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-002 8679544 2030-04-23 Drug product 2014-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-002 8999387 2030-04-23 U-55 2015-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-002 9017721 2030-04-23 Drug product 2015-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-002 9173854 2030-04-23 Drug product 2015-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-002 9180095 2030-04-23 U-55 2015-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-002 9180096 2030-04-23 Drug product 2015-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204592-002 9186328 2030-04-23 U-55 2015-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204592-001 8679544 2030-04-23 Drug product 2014-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-001 8999387 2030-04-23 U-55 2015-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-001 9017721 2030-04-23 Drug product 2015-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-001 9173854 2030-04-23 Drug product 2015-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-001 9180095 2030-04-23 U-55 2015-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-001 9180096 2030-04-23 Drug product 2015-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-001 9186328 2030-04-23 U-55 2015-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-002 8679544 2030-04-23 Drug product 2014-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-002 8999387 2030-04-23 U-55 2015-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-002 9017721 2030-04-23 Drug product 2015-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-002 9173854 2030-04-23 Drug product 2015-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-002 9180095 2030-04-23 U-55 2015-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-002 9180096 2030-04-23 Drug product 2015-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204592-002 9186328 2030-04-23 U-55 2015-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-001 8679544 2030-04-23 Drug product 2014-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-001 8999387 2030-04-23 U-55 2015-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-001 9017721 2030-04-23 Drug product 2015-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-001 9173854 2030-04-23 Drug product 2015-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-001 9180095 2030-04-23 U-55 2015-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-001 9180096 2030-04-23 Drug product 2015-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-001 9186328 2030-04-23 U-55 2015-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-002 8679544 2030-04-23 Drug product 2014-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-002 8999387 2030-04-23 U-55 2015-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-002 9017721 2030-04-23 Drug product 2015-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-002 9173854 2030-04-23 Drug product 2015-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204592-002 9180095 2030-04-23 U-55 2015-11-12 31067a03dcf5…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69344-204-29 69344020429 90 CAPSULE in 1 BOTTLE (69344-204-29) 90 capsule 2019-02-04 0000-00-00 No No Current