Diclofenac Sodium

Product NDC: 43353-784
11-digit product format: 433530784
Labeler code: 43353
Product ID: 43353-784_fd5924d8-e3f8-4164-81d6-2a5aea0dd202
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Application: ANDA075185
Marketing category: ANDA
Marketing start: 1998-11-13
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 50 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: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 product	product	43353-784		I	Inactivated by FDA		2026-08-03
excluded package	package	43353-784	43353-784-53	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-784-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-784-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-784-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-784-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-784-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-784-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-784-53	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-784-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-784-53	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-784-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-784-53	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-784-53	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-784-53	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-784-53	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-784-53	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-784-53	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-784-53	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-784-53	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-784-53	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-784-53	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-784-53	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	43353-784-53	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075185-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13
A075185-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13
A075185-003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075185-001	AB
A075185-002	AB
A075185-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075185-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075185-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075185-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075185-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075185-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075185-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075185-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075185-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075185-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075185-001	AB	1	`8072bd15b7f6…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-784-53	2019-11-13	C162847	48780-1	97449f38-b582-f6ea-e053-dbdaa90aa703	Diclofenac Sodium Delayed-release Tablets, USP 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-784-53	Diclofenac Sodium	60 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-784-53	EA - Each	43353-784	57db3fb2-0703-4d4b-8d59-35979c630543	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diclofenac Sodium	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
Diclofenac	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
Shellac	INACTIVE INGREDIENT	46N107B71O	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
Triethyl Citrate	INACTIVE INGREDIENT	8Z96QXD6UM	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-784	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1	Legacy NDC, 1 package rows	20120709_0c4281ab-1cd8-4e45-904c-9b9f5940c3bb.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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	ddd2278b-70be-41ca-8a84-e3fe0f1a1561	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	30c7e4fd-30af-4d28-a6ef-7386ff83cfb8	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	10991fe6-fafd-49af-9684-83b447c19c67	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium D/R	DICLOFENAC SODIUM D/R	DirectRx	50886f90-8cd0-4d38-e063-6294a90a44e4	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	7e940ce5-0f82-4d07-b507-c644481879c1	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	e947653c-6789-4c15-82c9-4b1402f6d6ac	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Redpharm Drug	4cd2e51b-2019-6eb6-e063-6294a90ad7ef	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	0cefb675-c54e-44eb-b35c-38354b77eddd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	74011b00-7e2e-40a7-ab30-c05a20559814	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	468fab22-2b69-4a2c-e063-6294a90aab9a	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium	DICLOFENAC SODIUM	AvKARE	19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	14c1b1a1-bc06-4722-9612-e88ae52272bc	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	c16e7e43-3869-9fef-e053-2995a90a1fdb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	f2b7ea75-738b-54a8-e053-2995a90a00d5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	47a7a294-55bb-8d19-e063-6394a90a5440	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	40388047-7fbe-49bf-bed8-e5087bed4e03	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	4a88f136-f7c7-47d7-b85d-8a2f9f118f09	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	58063c26-86fe-4f03-97ef-51706e5f4054	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	4539e9e7-5d82-3b36-e063-6394a90a1396	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	b8072af2-9940-4827-9fbd-de46ad8bf929	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	0c4281ab-1cd8-4e45-904c-9b9f5940c3bb	1
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	0c4281ab-1cd8-4e45-904c-9b9f5940c3bb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-784-53	43353078453	60 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Delayed-release Tablets, USP 50 mg	Aphena Pharma Solutions - Tennessee, Inc. \| Apace Packaging \| Carlsbad Technology, Inc.	2012-07-05	HUMAN PRESCRIPTION DRUG LABEL	1