Diclofenac Potassium

Product NDC: 0781-5017
11-digit product format: 007815017
Labeler code: 0781
Product ID: 0781-5017_4e5982d2-b61e-4aee-8d25-3fca8ecff7b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA075229
Marketing category: ANDA
Marketing start: 1998-11-20
Marketing end: 2020-08-31
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-5017		D	Discontinued by firm	2026-08-17
excluded package	package	0781-5017	0781-5017-01	D	Discontinued by firm	2026-08-17
excluded package	package	0781-5017	0781-5017-10	D	Discontinued by firm	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 1 · 36 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	0781-5017-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5017-10	`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	0781-5017-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5017-10	`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	0781-5017-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5017-10	`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	0781-5017-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5017-10	`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	0781-5017-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5017-10	`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	0781-5017-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5017-10	`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	0781-5017-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5017-10	`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	0781-5017-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5017-10	`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	0781-5017-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5017-10	`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	0781-5017-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5017-10	`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	0781-5017-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-5017-10	`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	0781-5017-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-5017-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5017-01	EA - Each	0781-5017	7f240724-ca98-4237-8ca5-2cd7253c6aa8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC POTASSIUM	ACTIVE INGREDIENT	L4D5UA6CB4	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]	14
DICLOFENAC POTASSIUM	ACTIVE INGREDIENT	L4D5UA6CB4	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	13

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Potassium Tablets, USP 50 mg	PD-Rx Pharmaceuticals, Inc.	2019-05-08	HUMAN PRESCRIPTION DRUG LABEL	19
Diclofenac Potassium Tablets, USP 50 mg	Sandoz Inc	2019-02-13	HUMAN PRESCRIPTION DRUG LABEL	17
Diclofenac Potassium Tablets, USP 50 mg	A-S Medication Solutions	2017-10-13	HUMAN PRESCRIPTION DRUG LABEL	4