Home NDC 42211-204 Zorvolex
Product NDC 42211-204
11-digit product format 422110204
Labeler code 42211
Product ID 42211-204_73b05aef-df1b-4b6c-8409-021f697deae1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac
Dosage form CAPSULE
Route ORAL
Labeler Iroko Pharmaceuticals LLC
Application NDA204592
Marketing category NDA
Marketing start 2013-10-31
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 2020-12-31
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 2 · 76 matching rows.
View current auxiliary records. · View the auxiliary file history.
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date N204592-001 ZORVOLEX DICLOFENAC 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 N204592-002 ZORVOLEX DICLOFENAC 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18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…
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 42211-204-23 Zorvolex 30 in 1 BOTTLE CAPSULE 30 7 42211-204-29 Zorvolex 90 in 1 BOTTLE CAPSULE 90 7 42211-204-43 Zorvolex 1 in 1 CARTON CAPSULE 1 7 42211-204-43 Zorvolex 3 in 1 BLISTER PACK CAPSULE 3 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42211-204 ZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC] 7 Legacy NDC, 4 package rows 20190411_dff10e66-a577-451d-ba75-1889458ca833.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42211-204-23 42211020423 30 in 1 BOTTLE Historical 42211-204-29 42211020429 90 in 1 BOTTLE Historical 42211-204-43 42211020443 1 in 1 CARTON Historical