ZIPSOR

Product NDC: 13913-008
11-digit product format: 139130008
Labeler code: 13913
Product ID: 13913-008_73f6a60d-3089-4936-84df-8c28c49cb441
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac potassium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Assertio Therapeutics, Inc.
Application: NDA022202
Marketing category: NDA
Marketing start: 2009-06-16
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	13913-008	13913-008-11	D	Discontinued by firm		2026-08-17
excluded package	package	13913-008	13913-008-94	D	Discontinued by firm		2026-08-17

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, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	13913-008-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	13913-008-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	13913-008-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	13913-008-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	13913-008-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	13913-008-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	13913-008-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	13913-008-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	13913-008-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	13913-008-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	13913-008-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	13913-008-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	13913-008-94	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	13913-008-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	13913-008-94	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	13913-008-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	13913-008-94	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	13913-008-11	`0efc9e666f02…`	`f202fb6c5f17…`

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
N022202-001	ZIPSOR	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022202-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	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.

Product history page 1 of 2 · 42 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	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…`
2022-09-29 23:25 UTC	2022-09	N022202-001	ZIPSOR	25MG	CAPSULE / ORAL	AB	RLD, RS	2009-06-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N022202-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 260 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022202-001	8623920	2029-02-24	U-1482	2014-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022202-001	9561200	2029-02-24	U-1482	2017-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022202-001	7662858	2029-02-24	U-1035		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022202-001	7884095	2029-02-24	U-1111	2011-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022202-001	7939518	2029-02-24	U-980	2011-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022202-001	8110606	2029-02-24	U-980	2012-02-13	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ZIPSOR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC POTASSIUM	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L4D5UA6CB4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858342	Internal RxNorm lookup
858346	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c982eca0-fc41-11e1-a9c8-0002a5d5c51b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13913-008-11	ZIPSOR	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	15
13913-008-12	ZIPSOR	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120	15
13913-008-94	ZIPSOR	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	15
13913-008-94	ZIPSOR	4 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	4	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13913-008-11	EA - Each	13913-008	fda93636-a415-4c53-a647-71d9bd699035	1	2013-05-02
13913-008-12	EA - Each	13913-008	b8ec7123-b3f3-4d97-96ae-cde6b349b34a	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC POTASSIUM	ACTIVE INGREDIENT	L4D5UA6CB4	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13913-008	ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [ASSERTIO THERAPEUTICS, INC.]	14	Current NDC, Legacy NDC, 4 package rows	20241215_c982eca0-fc41-11e1-a9c8-0002a5d5c51b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZIPSOR	DICLOFENAC POTASSIUM	Assertio Therapeutics, Inc.	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	2025-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022202 application number: NDA022202 ndc (product): 13913-008
Diclofenac Potassium	DICLOFENAC POTASSIUM	Leading Pharma, LLC	698690a7-4978-4457-b123-0a670bbab481	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022202 application number: NDA022202
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	69ab6f91-5770-480c-8bd1-8c1f1f8bfdb5	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022202 application number: NDA022202

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L4D5UA6CB4	DICLOFENAC POTASSIUM	15307-81-0	DICLOFENAC POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858342	diclofenac potassium 25 MG Oral Capsule	PSN	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	15
858346	Zipsor 25 MG Oral Capsule	PSN	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	15
858346	diclofenac 25 MG Oral Capsule [Zipsor]	SBD	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	15
858342	diclofenac 25 MG Oral Capsule	SCD	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	15
858342	diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral Capsule	SY	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	15
858346	Zipsor 25 MG Oral Capsule	SY	c982eca0-fc41-11e1-a9c8-0002a5d5c51b	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13913-008-11	13913000811	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-11)		2009-06-16	0000-00-00	No	No	Current
13913-008-12	13913000812	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)		2015-12-01	0000-00-00	No	No	Current
13913-008-94	13913000894	1 BLISTER PACK in 1 CARTON (13913-008-94) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2009-06-16	0000-00-00	No	No	Current