ZIPSOR
- Product NDC
- 82497-008
- 11-digit product format
- 824970008
- Labeler code
- 82497
- Product ID
- 82497-008_5a0953ef-56b9-08cb-e063-6294a90a45b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac potassium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Assertio Specialty Pharmaceuticals LLC
- Application
- NDA022202
- Marketing category
- NDA
- Marketing start
- 2026-08-24
- Substance
- DICLOFENAC POTASSIUM
- Active strength
- 25 mg/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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022202-001 | ZIPSOR | DICLOFENAC POTASSIUM | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022202-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022202-001 | 7662858 | 2029-02-24 | U-1035 | ||
| N022202-001 | 7884095 | 2029-02-24 | U-1111 | 2011-02-22 | |
| N022202-001 | 7939518 | 2029-02-24 | U-980 | 2011-05-19 | |
| N022202-001 | 8110606 | 2029-02-24 | U-980 | 2012-02-13 | |
| N022202-001 | 8623920 | 2029-02-24 | U-1482 | 2014-02-05 | |
| N022202-001 | 9561200 | 2029-02-24 | U-1482 | 2017-02-14 |
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 | 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 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022202-001 | ZIPSOR | 25MG | CAPSULE / ORAL | AB | RLD, RS | 2009-06-16 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022202-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022202-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022202-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022202-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022202-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022202-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022202-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022202-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022202-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022202-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022202-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022202-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022202-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022202-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022202-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022202-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022202-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022202-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022202-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022202-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022202-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022202-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022202-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022202-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022202-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022202-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022202-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022202-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022202-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022202-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022202-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022202-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022202-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022202-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022202-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022202-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022202-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022202-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022202-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022202-001 | AB | 1 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022202-001 | 7662858 | 2029-02-24 | U-1035 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022202-001 | 7884095 | 2029-02-24 | U-1111 | 2011-02-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022202-001 | 7939518 | 2029-02-24 | U-980 | 2011-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022202-001 | 8110606 | 2029-02-24 | U-980 | 2012-02-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022202-001 | 8623920 | 2029-02-24 | U-1482 | 2014-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022202-001 | 9561200 | 2029-02-24 | U-1482 | 2017-02-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022202-001 | 7662858 | 2029-02-24 | U-1035 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022202-001 | 7884095 | 2029-02-24 | U-1111 | 2011-02-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022202-001 | 7939518 | 2029-02-24 | U-980 | 2011-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022202-001 | 8110606 | 2029-02-24 | U-980 | 2012-02-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022202-001 | 8623920 | 2029-02-24 | U-1482 | 2014-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022202-001 | 9561200 | 2029-02-24 | U-1482 | 2017-02-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022202-001 | 7662858 | 2029-02-24 | U-1035 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022202-001 | 7884095 | 2029-02-24 | U-1111 | 2011-02-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022202-001 | 7939518 | 2029-02-24 | U-980 | 2011-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022202-001 | 8110606 | 2029-02-24 | U-980 | 2012-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022202-001 | 8623920 | 2029-02-24 | U-1482 | 2014-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022202-001 | 9561200 | 2029-02-24 | U-1482 | 2017-02-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022202-001 | 7662858 | 2029-02-24 | U-1035 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022202-001 | 7884095 | 2029-02-24 | U-1111 | 2011-02-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022202-001 | 7939518 | 2029-02-24 | U-980 | 2011-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022202-001 | 8110606 | 2029-02-24 | U-980 | 2012-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022202-001 | 8623920 | 2029-02-24 | U-1482 | 2014-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022202-001 | 9561200 | 2029-02-24 | U-1482 | 2017-02-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022202-001 | 7662858 | 2029-02-24 | U-1035 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022202-001 | 7884095 | 2029-02-24 | U-1111 | 2011-02-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022202-001 | 7939518 | 2029-02-24 | U-980 | 2011-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022202-001 | 8110606 | 2029-02-24 | U-980 | 2012-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022202-001 | 8623920 | 2029-02-24 | U-1482 | 2014-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022202-001 | 9561200 | 2029-02-24 | U-1482 | 2017-02-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022202-001 | 7662858 | 2029-02-24 | U-1035 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022202-001 | 7884095 | 2029-02-24 | U-1111 | 2011-02-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022202-001 | 7939518 | 2029-02-24 | U-980 | 2011-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022202-001 | 8110606 | 2029-02-24 | U-980 | 2012-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022202-001 | 8623920 | 2029-02-24 | U-1482 | 2014-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022202-001 | 9561200 | 2029-02-24 | U-1482 | 2017-02-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022202-001 | 7662858 | 2029-02-24 | U-1035 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022202-001 | 7884095 | 2029-02-24 | U-1111 | 2011-02-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022202-001 | 7939518 | 2029-02-24 | U-980 | 2011-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022202-001 | 8110606 | 2029-02-24 | U-980 | 2012-02-13 | b8a1b40f171c… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022202-001 | NPP | 2024-05-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022202-001 | NPP | 2024-05-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022202-001 | NPP | 2024-05-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022202-001 | NPP | 2024-05-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022202-001 | NPP | 2024-05-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022202-001 | NPP | 2024-05-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022202-001 | NPP | 2024-05-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022202-001 | NPP | 2024-05-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022202-001 | NPP | 2024-05-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022202-001 | NPP | 2024-05-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022202-001 | NPP | 2024-05-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022202-001 | NPP | 2024-05-25 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N022202-001 | NPP | 2024-05-25 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022202-001 | NPP | 2024-05-25 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022202-001 | NPP | 2024-05-25 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022202-001 | NPP | 2024-05-25 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022202-001 | NPP | 2024-05-25 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022202-001 | NPP | 2024-05-25 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022202-001 | NPP | 2024-05-25 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022202-001 | NPP | 2024-05-25 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022202-001 | NPP | 2024-05-25 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022202-001 | NPP | 2024-05-25 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022202-001 | NPP | 2024-05-25 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022202-001 | NPP | 2024-05-25 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022202-001 | NPP | 2024-05-25 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022202-001 | NPP | 2024-05-25 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022202-001 | NPP | 2024-05-25 | cb3db0bc1861… |
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
- ZIPSOR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOFENAC POTASSIUM | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L4D5UA6CB4 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ed2a8868-78eb-47b8-8f46-0f70e2891e07 | Available on FDA.report |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ZIPSOR | DICLOFENAC POTASSIUM | Assertio Specialty Pharmaceuticals LLC | ed2a8868-78eb-47b8-8f46-0f70e2891e07 | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 022202 NDA022202 82497-008 |
| ZIPSOR | DICLOFENAC POTASSIUM | Assertio Therapeutics, Inc. | c982eca0-fc41-11e1-a9c8-0002a5d5c51b | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | 022202 NDA022202 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Leading Pharma, LLC | 698690a7-4978-4457-b123-0a670bbab481 | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | 022202 NDA022202 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Bryant Ranch Prepack | 69ab6f91-5770-480c-8bd1-8c1f1f8bfdb5 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | 022202 NDA022202 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 82497-008-12 | 82497000812 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (82497-008-12) | 2026-08-24 | No | No | Current |