Application 204623

Type: NDA
Sponsor: HORIZON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENNSAID	DICLOFENAC SODIUM	SOLUTION;TOPICAL	2%	Yes	Yes

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
N204623-001	PENNSAID	DICLOFENAC SODIUM	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204623-001	8563613	2027-10-17	U-1488	Drug product	2014-02-25
N204623-001	8871809	2027-10-17	U-1614		2014-11-18
N204623-001	9066913	2027-10-17	U-1488	Drug product	2015-06-30
N204623-001	9101591	2027-10-17	U-1488	Drug product	2015-08-11
N204623-001	9132110	2027-10-17	U-1488		2015-09-16
N204623-001	9168304	2027-10-17		Drug product	2015-10-27
N204623-001	9168305	2027-10-17	U-1488		2015-10-27
N204623-001	9220784	2027-10-17	U-1488		2016-01-28
N204623-001	9339551	2027-10-17	U-1488		2016-06-16
N204623-001	9339552	2027-10-17	U-1488	Drug product	2016-06-16
N204623-001	9539335	2027-10-17	U-1614		2016-02-06
N204623-001	8252838	2028-04-21	U-1489	Drug product	2014-02-25
N204623-001	8217078	2029-07-10	U-1477		2014-02-25
N204623-001	8618164	2029-07-10	U-1477		2014-02-25
N204623-001	8741956	2029-07-10	U-1435		2014-06-05
N204623-001	9370501	2029-07-10	U-1614		2016-07-19
N204623-001	9375412	2029-07-10	U-1614		2016-07-26
N204623-001	9415029	2029-07-10	U-1614		2016-09-13
N204623-001	8546450	2030-08-09	U-1435		2014-02-25
N204623-001	8546450	2030-08-09	U-1436		2014-02-25

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	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD	2014-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD	2014-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD	2014-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD	2014-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204623-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204623-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204623-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204623-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204623-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204623-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204623-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204623-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204623-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204623-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204623-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204623-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204623-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204623-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 840 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	N204623-001	8563613	2027-10-17	U-1488	Drug product	2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8871809	2027-10-17	U-1614		2014-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9066913	2027-10-17	U-1488	Drug product	2015-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9101591	2027-10-17	U-1488	Drug product	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9132110	2027-10-17	U-1488		2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9168304	2027-10-17		Drug product	2015-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9168305	2027-10-17	U-1488		2015-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9220784	2027-10-17	U-1488		2016-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9339551	2027-10-17	U-1488		2016-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9339552	2027-10-17	U-1488	Drug product	2016-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9539335	2027-10-17	U-1614		2016-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8252838	2028-04-21	U-1489	Drug product	2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8217078	2029-07-10	U-1477		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8618164	2029-07-10	U-1477		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8741956	2029-07-10	U-1435		2014-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9370501	2029-07-10	U-1614		2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9375412	2029-07-10	U-1614		2016-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9415029	2029-07-10	U-1614		2016-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8546450	2030-08-09	U-1435		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8546450	2030-08-09	U-1436		2014-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8563613	2027-10-17	U-1488	Drug product	2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8871809	2027-10-17	U-1614		2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9066913	2027-10-17	U-1488	Drug product	2015-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9101591	2027-10-17	U-1488	Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9132110	2027-10-17	U-1488		2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9168304	2027-10-17		Drug product	2015-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9168305	2027-10-17	U-1488		2015-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9220784	2027-10-17	U-1488		2016-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9339551	2027-10-17	U-1488		2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9339552	2027-10-17	U-1488	Drug product	2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9539335	2027-10-17	U-1614		2016-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8252838	2028-04-21	U-1489	Drug product	2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8217078	2029-07-10	U-1477		2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8618164	2029-07-10	U-1477		2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8741956	2029-07-10	U-1435		2014-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9370501	2029-07-10	U-1614		2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9375412	2029-07-10	U-1614		2016-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9415029	2029-07-10	U-1614		2016-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8546450	2030-08-09	U-1435		2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8546450	2030-08-09	U-1436		2014-02-25	`011fe1cb6892…`

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 14 · 274 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMAZON BASIC CARE ARTHRITIS PAIN	DICLOFENAC SODIUM	Amazon.com Services LLC	113e2f87-c408-3e44-e063-6394a90a0a7f	2026-08-20	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	e9ec5462-939a-4022-8946-5d81869a6277	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	2a7019e9-e20f-4897-9b8e-942a7f2b34f6	2026-08-12	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	226da8a2-807d-4784-8d33-b434f3951a52	2026-08-12	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	681b6b25-4a28-44f2-8042-d5e01a502116	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	Care One (Retail Business Services, LLC.)	4484a332-aab1-46a9-aca8-159e7a09439f	2026-08-12	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	57c83158-f072-6fa2-e063-6394a90aee2c	2026-07-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	ddd2278b-70be-41ca-8a84-e3fe0f1a1561	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	CVS Pharmacy	591cc2ed-e667-4779-a426-8a2e6f873573	2026-07-22	Warnings	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	d9b6f1d0-1710-46fb-8ea4-80b3ca60a575	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	HAWAII REPACK, INC	ea113a58-c7ed-4768-9777-93d9b166dfbe	2026-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	63c00b50-06d3-4659-81cf-be4516429e81	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	6e6a6f98-5517-4f67-9a6a-71019ba2d773	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	71a823c4-9c88-474d-b525-276f9e7808aa	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	09643e65-f301-4891-96f4-d78bf3621e23	2026-07-02	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	30c7e4fd-30af-4d28-a6ef-7386ff83cfb8	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	dbb1489d-b690-4e53-905d-7fb07ad263b3	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEF	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	84978746-4ab5-456d-af63-5c86ab0a05f5	2026-06-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	10991fe6-fafd-49af-9684-83b447c19c67	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	6980431d-4a2b-41e9-ae86-d46b4513f04b	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-0167	DICLOFENAC SODIUM	diclofenac sodium	Padagis US LLC	NDA AUTHORIZED GENERIC	Current
63629-9603	DICLOFENAC SODIUM	diclofenac sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
70518-2492	Pennsaid	diclofenac sodium	REMEDYREPACK INC.	NDA	Current
70518-2492	Pennsaid	diclofenac sodium	REMEDYREPACK INC.	NDA	Current
70518-2492	Pennsaid	diclofenac sodium	REMEDYREPACK INC.	NDA	Current
70518-2492	Pennsaid	diclofenac sodium	REMEDYREPACK INC.	NDA	Current
70518-2492	Pennsaid	diclofenac sodium	REMEDYREPACK INC.	NDA	Current
70748-335	Diclofenac Sodium	Diclofenac Sodium	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
75987-040	Pennsaid	diclofenac sodium	Horizon Therapeutics USA, Inc.	NDA	Current
75987-040	Pennsaid	diclofenac sodium	Horizon Therapeutics USA, Inc.	NDA	Current
75987-040	Pennsaid	diclofenac sodium	Horizon Therapeutics USA, Inc.	NDA	Current
75987-040	Pennsaid	diclofenac sodium	Horizon Therapeutics USA, Inc.	NDA	Current
75987-040	Pennsaid	diclofenac sodium	Horizon Therapeutics USA, Inc.	NDA	Current
75987-040	Pennsaid	diclofenac sodium	Horizon Therapeutics USA, Inc.	NDA	Current
75987-040	Pennsaid	diclofenac sodium	Horizon Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80396	SUPPL	2024-11-25
80395	SUPPL	2024-11-25
80314	SUPPL	2024-11-22
70017	SUPPL	2022-01-31
70004	SUPPL	2022-01-31
67745	SUPPL	2021-06-08
67744	SUPPL	2021-06-08
67734	SUPPL	2021-06-08
67362	SUPPL	2021-05-03
67361	SUPPL	2021-05-03
67287	SUPPL	2021-04-30
63564	SUPPL	2020-06-15
63486	SUPPL	2020-06-11
40400	SUPPL	2016-05-11
10366	SUPPL	2016-05-10
40399	SUPPL	2014-11-07
10365	SUPPL	2014-11-07
43469	ORIG	2014-10-07
24473	ORIG	2014-10-07
19576	SUPPL	2014-07-11
40398	ORIG	2014-01-17
10364	ORIG	2014-01-17