Diclofenac Sodium

Product NDC: 0591-0676
11-digit product format: 005910676
Labeler code: 0591
Product ID: 0591-0676_d0c01e3f-d243-420f-bc47-e31141459e12
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA076201
Marketing category: ANDA
Marketing start: 2002-11-06
Marketing end: 2019-10-31
Substance: DICLOFENAC SODIUM
Active strength: 100 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: 0000-00-00
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	0591-0676		D	Discontinued by firm		2026-08-11
excluded package	package	0591-0676	0591-0676-01	D	Discontinued by firm		2026-08-11

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 · 24 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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`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	0591-0676-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A076201-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076201-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076201-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2002-11-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A076201-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076201-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076201-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076201-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076201-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076201-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076201-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076201-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076201-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076201-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076201-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076201-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076201-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076201-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076201-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076201-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076201-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076201-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076201-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076201-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076201-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076201-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076201-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076201-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076201-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076201-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076201-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076201-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076201-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076201-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076201-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076201-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076201-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076201-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076201-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076201-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076201-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076201-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076201-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076201-001	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-0676-01	EA - Each	0591-0676	df52802a-fb3a-45a5-a444-62244ee7225c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	8
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	ST. MARY'S MEDICAL PARK PHARMACY	4ddd7e34-e5f4-8f05-e063-6294a90a70aa	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076201 application number: ANDA076201
Diclofenac Sodium	DICLOFENAC SODIUM	Edenbridge Pharmaceuticals LLC.	bd25a2b1-a4d5-4893-97d1-efdcd414a97d	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076201 application number: ANDA076201
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	0d1d19e5-4ffe-af95-e063-6394a90a7abf	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076201 application number: ANDA076201
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, LLC.	26e44aa5-cfcd-f10b-e063-6394a90a4dcf	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076201 application number: ANDA076201

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
855657	diclofenac sodium 100 MG 24HR Extended Release Oral Tablet	PSN	753dd45e-7135-438a-9aa7-990cf5f97c6d	8
855657	24 HR diclofenac sodium 100 MG Extended Release Oral Tablet	SCD	753dd45e-7135-438a-9aa7-990cf5f97c6d	8
855657	diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet	SY	753dd45e-7135-438a-9aa7-990cf5f97c6d	8
855657	diclofenac sodium 100 MG 24HR Extended Release Oral Tablet	PSN	aa20910b-c01e-454c-9224-1226e7c97c0b	7
855657	24 HR diclofenac sodium 100 MG Extended Release Oral Tablet	SCD	aa20910b-c01e-454c-9224-1226e7c97c0b	7
855657	diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet	SY	aa20910b-c01e-454c-9224-1226e7c97c0b	7
855657	diclofenac sodium 100 MG 24HR Extended Release Oral Tablet	PSN	7cf9cdc3-6837-4b64-b967-9d15f3b0bdc4	1
855657	diclofenac sodium 100 MG 24HR Extended Release Oral Tablet	PSN	d3688090-07ca-4802-a865-60843b0d83ab	1
855657	24 HR diclofenac sodium 100 MG Extended Release Oral Tablet	SCD	7cf9cdc3-6837-4b64-b967-9d15f3b0bdc4	1
855657	24 HR diclofenac sodium 100 MG Extended Release Oral Tablet	SCD	d3688090-07ca-4802-a865-60843b0d83ab	1
855657	diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet	SY	7cf9cdc3-6837-4b64-b967-9d15f3b0bdc4	1
855657	diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet	SY	d3688090-07ca-4802-a865-60843b0d83ab	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Extended-release Tablets	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	3
Diclofenac Sodium Extended-release Tablets	NuCare Pharmaceuticals, Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium Extended-release Tablets	Proficient Rx LP	2019-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Diclofenac Sodium Extended-release Tablets	NuCare Pharmaceuticals, Inc.	2018-11-28	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium Extended-release Tablets	A-S Medication Solutions	2018-08-29	HUMAN PRESCRIPTION DRUG LABEL	7
Diclofenac Sodium Extended-release Tablets	Bryant Ranch Prepack	2018-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium Extended-release Tablets	Unit Dose Services	2016-08-03	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium Extended-release Tablets	Blenheim Pharmacal, Inc.	2015-10-08	HUMAN PRESCRIPTION DRUG LABEL	8
DICLOFENAC SODIUM	Direct RX	2015-06-30	HUMAN PRESCRIPTION DRUG LABEL	1