DICLOFENAC POTASSIUM

Product NDC: 12634-827
11-digit product format: 126340827
Labeler code: 12634
Product ID: 12634-827_bf8d9912-f32f-41d3-8173-a60c80fddc77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICLOFENAC POTASSIUM
Dosage form: TABLET
Route: ORAL
Labeler: APOTHECA, INC
Application: ANDA075229
Marketing category: ANDA
Marketing start: 2007-08-20
Marketing end: 0000-00-00
Substance: DICLOFENAC POTASSIUM
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: No
Listing certified through: 2019-12-31
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 · 14 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-827		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-50	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-54	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-59	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-60	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-61	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-78	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-81	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-84	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-827	12634-827-91	I	Inactivated by FDA	2026-08-17

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 · 294 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	12634-827-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-827-54	`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	12634-827-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-827-54	`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	12634-827-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-81	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-827-54	`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	12634-827-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-84	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-81	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-827-54	`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	12634-827-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-827-59	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-827-91	`cfe11265f3b6…`	`090c488252e2…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075229-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20
A075229-002	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075229-001	AB
A075229-002	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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	RS	1998-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075229-002	DICLOFENAC POTASSIUM	25MG	TABLET / ORAL	AB		2021-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075229-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-11-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075229-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075229-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075229-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075229-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075229-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075229-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075229-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075229-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075229-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075229-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075229-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075229-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075229-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075229-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075229-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075229-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075229-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075229-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075229-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075229-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075229-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075229-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075229-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075229-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075229-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075229-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075229-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075229-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075229-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075229-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075229-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075229-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075229-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075229-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075229-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075229-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075229-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075229-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075229-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075229-001	AB	1	`782e0a99824c…`

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
12634-827-00	DICLOFENAC POTASSIUM, TABLET USP
12634-827-50	DICLOFENAC POTASSIUM, TABLET USP
12634-827-54	DICLOFENAC POTASSIUM, TABLET USP
12634-827-59	DICLOFENAC POTASSIUM, TABLET USP
12634-827-60	DICLOFENAC POTASSIUM, TABLET USP
12634-827-61	DICLOFENAC POTASSIUM, TABLET USP
12634-827-71	DICLOFENAC POTASSIUM, TABLET USP
12634-827-78	DICLOFENAC POTASSIUM, TABLET USP
12634-827-80	DICLOFENAC POTASSIUM, TABLET USP
12634-827-81	DICLOFENAC POTASSIUM, TABLET USP
12634-827-84	DICLOFENAC POTASSIUM, TABLET USP
12634-827-85	DICLOFENAC POTASSIUM, TABLET USP
12634-827-91	DICLOFENAC POTASSIUM, TABLET USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-827-00	DICLOFENAC POTASSIUM	10 in 1 BOTTLE	TABLET	10	1
12634-827-50	DICLOFENAC POTASSIUM	50 in 1 BOTTLE	TABLET	50	1
12634-827-54	DICLOFENAC POTASSIUM	14 in 1 BLISTER PACK	TABLET	14	1
12634-827-59	DICLOFENAC POTASSIUM	30 in 1 BLISTER PACK	TABLET	30	1
12634-827-60	DICLOFENAC POTASSIUM	60 in 1 BOTTLE	TABLET	60	1
12634-827-61	DICLOFENAC POTASSIUM	10 in 1 BLISTER PACK	TABLET	10	1
12634-827-71	DICLOFENAC POTASSIUM	30 in 1 BOTTLE	TABLET	30	1
12634-827-78	DICLOFENAC POTASSIUM	28 in 1 BOTTLE	TABLET	28	1
12634-827-80	DICLOFENAC POTASSIUM	20 in 1 BOTTLE	TABLET	20	1
12634-827-81	DICLOFENAC POTASSIUM	21 in 1 BOTTLE	TABLET	21	1
12634-827-84	DICLOFENAC POTASSIUM	14 in 1 BOTTLE	TABLET	14	1
12634-827-85	DICLOFENAC POTASSIUM	15 in 1 BOTTLE	TABLET	15	1
12634-827-91	DICLOFENAC POTASSIUM	1 in 1 BOTTLE	TABLET	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC POTASSIUM	ACTIVE INGREDIENT	L4D5UA6CB4	DICLOFENAC POTASSIUM TABLET [APOTHECA, INC]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC POTASSIUM TABLET [APOTHECA, INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC POTASSIUM TABLET [APOTHECA, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-827	DICLOFENAC POTASSIUM TABLET [APOTHECA, INC]	1	Legacy NDC, 13 package rows	20131119_645c97bc-5197-45a1-9802-2b4d43bd7496.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	NuCare Pharmaceuticals,Inc.	d61cbb27-737d-948c-e053-2a95a90adaca	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	86461915-9bc1-43d4-8d92-6eef3e56bd90	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	Northwind Health Company, LLC	f2b6a4dd-e4e2-4acc-e053-2995a90aebf2	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	Advagen Pharma Ltd	82218d5c-1625-471a-aabe-f43338e5176b	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	Trifluent Pharma LLC	8fdb1036-c0d8-4288-ac37-6512b05672ef	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	INA Pharmaceutics Inc	5ecd99fe-cb74-4a65-9636-2aefd2416ece	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	Coupler LLC	2eead069-f954-abb2-e063-6394a90a14ff	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	A-S Medication Solutions	112e7c94-23c8-451e-ae71-eb89a6eb2cb2	2023-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229
Diclofenac Potassium	DICLOFENAC POTASSIUM	Proficient Rx LP	94586867-c75b-4d60-be1d-03a9e4b7cd10	2023-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075229 application number: ANDA075229

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L4D5UA6CB4	DICLOFENAC POTASSIUM	15307-81-0	DICLOFENAC POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855942	diclofenac potassium 50 MG Oral Tablet	PSN	645c97bc-5197-45a1-9802-2b4d43bd7496	1
855942	diclofenac potassium 50 MG Oral Tablet	SCD	645c97bc-5197-45a1-9802-2b4d43bd7496	1
855942	Diclofenac K+ 50 MG Oral Tablet	SY	645c97bc-5197-45a1-9802-2b4d43bd7496	1
855942	Diclofenac Pot 50 MG Oral Tablet	SY	645c97bc-5197-45a1-9802-2b4d43bd7496	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-827-00	12634082700	10 in 1 BOTTLE	Historical
12634-827-50	12634082750	50 in 1 BOTTLE	Historical
12634-827-54	12634082754	14 in 1 BLISTER PACK	Historical
12634-827-59	12634082759	30 in 1 BLISTER PACK	Historical
12634-827-60	12634082760	60 in 1 BOTTLE	Historical
12634-827-61	12634082761	10 in 1 BLISTER PACK	Historical
12634-827-71	12634082771	30 in 1 BOTTLE	Historical
12634-827-78	12634082778	28 in 1 BOTTLE	Historical
12634-827-80	12634082780	20 in 1 BOTTLE	Historical
12634-827-81	12634082781	21 in 1 BOTTLE	Historical
12634-827-84	12634082784	14 in 1 BOTTLE	Historical
12634-827-85	12634082785	15 in 1 BOTTLE	Historical
12634-827-91	12634082791	1 in 1 BOTTLE	Historical