Diclofenac Sodium

Product NDC: 52959-423
11-digit product format: 529590423
Labeler code: 52959
Product ID: 52959-423_6029c68a-8374-48c7-8690-74347e623cfe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA077863
Marketing category: ANDA
Marketing start: 2008-08-19
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: 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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-423		I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-02	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-10	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-14	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-15	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-20	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-21	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-28	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-30	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-60	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-423	52959-423-90	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 5 · 242 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	52959-423-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-423-02	`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	52959-423-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-423-02	`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	52959-423-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-423-02	`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	52959-423-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-423-02	`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	52959-423-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-423-02	`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	52959-423-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-423-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-423-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-423-30	`cdf11ea48f46…`	`ba0047e9e063…`

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
A077863-003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077863-003	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 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	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		2007-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		2007-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		2007-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`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	A077863-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077863-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077863-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077863-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077863-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077863-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077863-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077863-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077863-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077863-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077863-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077863-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077863-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077863-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077863-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077863-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077863-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077863-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077863-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077863-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077863-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077863-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077863-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077863-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077863-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077863-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077863-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077863-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077863-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077863-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077863-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077863-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077863-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077863-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077863-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077863-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077863-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077863-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077863-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077863-003	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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-423-02	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-10	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-14	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-15	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-20	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-21	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-28	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-30	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-60	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg
52959-423-90	Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-423-02	Diclofenac Sodium	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	3
52959-423-10	Diclofenac Sodium	10 in 1 BOTTLE	TABLET, DELAYED RELEASE	10	3
52959-423-14	Diclofenac Sodium	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	3
52959-423-15	Diclofenac Sodium	15 in 1 BOTTLE	TABLET, DELAYED RELEASE	15	3
52959-423-20	Diclofenac Sodium	20 in 1 BOTTLE	TABLET, DELAYED RELEASE	20	3
52959-423-21	Diclofenac Sodium	21 in 1 BOTTLE	TABLET, DELAYED RELEASE	21	3
52959-423-28	Diclofenac Sodium	28 in 1 BOTTLE	TABLET, DELAYED RELEASE	28	3
52959-423-30	Diclofenac Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	3
52959-423-60	Diclofenac Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	3
52959-423-90	Diclofenac Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-423-02	EA - Each	52959-423	6aeae13b-2492-4e3b-90e5-ef0ff0089a53	1	2012-07-24
52959-423-10	EA - Each	52959-423	36f037b6-c112-4e4b-b1bd-0d2bfb42ef3e	1	2012-07-24
52959-423-14	EA - Each	52959-423	ed40fd3b-b59d-4b6d-b4e4-b234c2815910	1	2012-07-24
52959-423-15	EA - Each	52959-423	82d6b8fb-837a-46d7-bebc-cab8c07c0e20	1	2012-07-24
52959-423-20	EA - Each	52959-423	32b7de43-f629-46c2-9373-ddd19f448ec8	1	2012-07-24
52959-423-21	EA - Each	52959-423	30cbc155-459a-40c9-ac36-236b7a86849f	1	2012-07-24
52959-423-28	EA - Each	52959-423	dc23485c-011e-4588-8204-f08f20f3a10c	1	2012-07-24
52959-423-30	EA - Each	52959-423	db070345-5079-461a-8cdf-4919d00837fd	1	2012-07-24
52959-423-60	EA - Each	52959-423	2a759f35-9f99-4ae7-873f-ba2e049646dd	1	2012-07-24
52959-423-90	EA - Each	52959-423	3065b401-3f9b-4f33-b123-718d74ee8d05	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diclofenac Sodium	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
Diclofenac	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
povidone	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-423	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3	Legacy NDC, 10 package rows	20120423_e424b30d-8f40-48b7-bb99-415f92d84ed0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	681b6b25-4a28-44f2-8042-d5e01a502116	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	dbb1489d-b690-4e53-905d-7fb07ad263b3	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	St. Mary's Medical Park Pharmacy	5f4b69de-8ddd-26c5-e053-2a91aa0ab326	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	1eb7a7bb-c524-4168-8ade-4601dc11533b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	ed1b5ec7-2812-4a81-90d1-953baa0b0ec8	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	e9ec5462-939a-4022-8946-5d81869a6277	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	47ce6fab-be1d-0076-e063-6294a90add63	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	BluePoint Laboratories	feb1541a-de83-47dd-be03-c43376527318	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Rising Pharma Holdings, Inc.	3330ea92-fc9d-4541-b378-be399b0995d3	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Coupler LLC	2ce0741a-7bc7-8aec-e063-6294a90ae9ef	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	62edf474-9c16-d535-e053-2991aa0a4a09	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac DR	DICLOFENAC	Advanced Rx of Tennessee, LLC	af8a30fb-ead8-7e29-e053-2a95a90a040f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	50efc183-dd3e-4eb7-ba5c-c42fd76e0b65	2023-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863

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
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	e424b30d-8f40-48b7-bb99-415f92d84ed0	3
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	e424b30d-8f40-48b7-bb99-415f92d84ed0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-423-02	52959042302	120 in 1 BOTTLE	Historical
52959-423-10	52959042310	10 in 1 BOTTLE	Historical
52959-423-14	52959042314	14 in 1 BOTTLE	Historical
52959-423-15	52959042315	15 in 1 BOTTLE	Historical
52959-423-20	52959042320	20 in 1 BOTTLE	Historical
52959-423-21	52959042321	21 in 1 BOTTLE	Historical
52959-423-28	52959042328	28 in 1 BOTTLE	Historical
52959-423-30	52959042330	30 in 1 BOTTLE	Historical
52959-423-60	52959042360	60 in 1 BOTTLE	Historical
52959-423-90	52959042390	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg	H.J. Harkins Company, Inc. \| Pack Pharmaceuticals, LLC \| Unique Pharmaceutical Laboratories	2012-04-19	HUMAN PRESCRIPTION DRUG LABEL	3