Home NDC 72989-458-55 LICART
Product NDC 72989-458
Requested package NDC 72989-458-55
11-digit product format 729890458
Labeler code 72989
Product ID 72989-458_4e555985-3056-0705-e063-6294a90a8c4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac epolamine
Dosage form SYSTEM
Route TOPICAL
Labeler Acertis Pharmaceuticals LLC
Application NDA206976
Marketing category NDA
Marketing start 2020-09-01
Substance DICLOFENAC EPOLAMINE
Active strength .013 g/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N206976-001 LICART DICLOFENAC EPOLAMINE 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206976-001 11344520 2035-02-20 U-3393 2022-06-29 N206976-001 11351133 2035-02-20 U-3393 2022-06-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N206976-001 NPP 2029-03-27
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 2 · 44 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 2026-10-15 13:18:30 2026-09 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD 2018-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD 2018-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD 2018-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD 2018-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206976-001 LICART 1.3% SYSTEM / TOPICAL RLD, RS 2018-12-19 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 2 · 62 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206976-001 11344520 2035-02-20 U-3393 2022-06-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N206976-001 11351133 2035-02-20 U-3393 2022-06-29 ea1830bbd6c7…
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 LICART
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC EPOLAMINE .013 g/1
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 LICART DICLOFENAC EPOLAMINE IBSA Pharma Inc. 851c8b39-6056-4bbc-812e-b9b13977c1ac 2026-04-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 206976 application number: NDA206976
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72989-458-55 72989045855 3 POUCH in 1 CARTON (72989-458-55) / 5 SYSTEM in 1 POUCH (72989-458-54) 3 pouch 2020-09-01 No No Current