Diclofenac Sodium

Product NDC: 55700-834
11-digit product format: 557000834
Labeler code: 55700
Product ID: 55700-834_46f2b119-efcd-497d-aefc-74029d190313
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA075185
Marketing category: ANDA
Marketing start: 2020-01-03
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 75 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: No
Listing certified through: 2022-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-834		D	Discontinued by firm	2026-10-05
excluded package	package	55700-834	55700-834-20	D	Discontinued by firm	2026-10-05
excluded package	package	55700-834	55700-834-30	D	Discontinued by firm	2026-10-05
excluded package	package	55700-834	55700-834-60	D	Discontinued by firm	2026-10-05
excluded package	package	55700-834	55700-834-90	D	Discontinued by firm	2026-10-05

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 2 · 75 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-834-20	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-834-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-834-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-834-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-834-20	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-834-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-834-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-834-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-834-20	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-834-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-834-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-834-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-834-20	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-834-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-834-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-834-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-834-20	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-834-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-834-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-834-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-834-20	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-834-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-834-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-834-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-834-20	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-834-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-834-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-834-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-834-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-834-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-834-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-834-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-834-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-834-20	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-834-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-834-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-834-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-834-20	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-834-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-834-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-834-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-834-20	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-834-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-834-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-834-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-834-20	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-834-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-834-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075185-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075185-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075185-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075185-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075185-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075185-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55700-834-20	2025-01-13	Diclofenac Sodium
55700-834-30	2025-01-13	Diclofenac Sodium
55700-834-60	2025-01-13	Diclofenac Sodium
55700-834-90	2025-01-13	Diclofenac Sodium
55700-834-20	2023-01-30	Diclofenac Sodium
55700-834-30	2023-01-30	Diclofenac Sodium
55700-834-60	2023-01-30	Diclofenac Sodium
55700-834-90	2023-01-30	Diclofenac Sodium

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-834-20	EA - Each	55700-834	a7f86123-54b0-4a2b-9979-b8d74570c291	1	2020-03-10
55700-834-30	EA - Each	55700-834	2355a6e4-cfa0-492a-b7bf-456790bf6c29	1	2020-03-10
55700-834-60	EA - Each	55700-834	03e93695-33f0-48a2-b774-d747cf460862	1	2020-03-10
55700-834-90	EA - Each	55700-834	65e2b8bd-41c7-4cc7-9cd1-d1da9c366722	1	2021-03-02

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 2 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	PHOENIX RX LLC	41472cca-278b-934b-e063-6294a90aaf5d	2025-11-14	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.	39e67a90-df3e-ad30-e063-6394a90a7a82	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Carlsbad Technology, Inc.	363764a0-e0a8-3e3f-e063-6294a90ad672	2025-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Carlsbad Technology, Inc.	40879600-ba6c-43a8-aa5d-d0d41503d593	2025-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium	DICLOFENAC SODIUM	RedPharm Drug, Inc.	4ecb7bdc-4a5e-7444-e054-00144ff88e88	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	c933eaad-ba53-4130-90db-a66f89dfc29f	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	5b4c1a15-ed93-7192-e053-2991aa0a8360	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium DR	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	d424ab84-2aaa-38a9-e053-2a95a90adde9	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium DR	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	ec06cca5-3436-10c8-e053-2995a90a4aeb	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium DR	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	af8a1392-67e8-8201-e053-2a95a90a0fce	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	ae0add8e-3a8a-4c5d-af3b-907f64211fef	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	70156824-e5dd-42b1-9b4f-a49acb28d316	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	2bebda5e-227e-4a49-80e3-191cfc805295	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	12cce748-a7de-4b1e-9603-b5c2ce12d531	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	2b7462e6-62dc-4b08-9fbf-5858e356a7a8	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	4b44ac98-225c-1739-e054-00144ff88e88	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	8bda6135-c957-6b4e-e053-2995a90a0cb5	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	629b77cf-f825-8640-e053-2991aa0a10a8	2024-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	7bf19e84-4f75-4d5c-9927-99220c58b572	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Bryant Ranch Prepack	df5bb0e7-a3a9-4650-aae7-9a11ce615d5d	2024-02-08	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-834-20	55700083420	20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-20)	2020-01-03	0000-00-00	No	No	Current
55700-834-30	55700083430	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-30)	2020-01-03	0000-00-00	No	No	Current
55700-834-60	55700083460	60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-60)	2020-01-03	0000-00-00	No	No	Current
55700-834-90	55700083490	90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-90)	2021-01-15	0000-00-00	No	No	Current