Diclofenac Potassium

Product NDC: 68071-2892
11-digit product format: 680712892
Labeler code: 68071
Product ID: 68071-2892_ef44236c-b3b9-6068-e053-2995a90a649c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA215585
Marketing category: ANDA
Marketing start: 2021-10-11
Marketing end: 0000-00-00
Substance: DICLOFENAC POTASSIUM
Active strength: 50 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2892		I	Inactivated by FDA		2026-08-17
excluded package	package	68071-2892	68071-2892-3	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 1 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2892-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2892-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2892-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2892-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2892-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2892-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2892-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2892-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2892-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
A215585-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		2021-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215585-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215585-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	2021-10-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215585-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215585-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215585-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215585-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215585-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215585-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215585-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215585-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215585-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215585-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215585-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215585-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215585-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215585-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215585-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215585-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215585-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215585-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215585-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215585-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215585-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215585-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215585-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215585-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215585-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215585-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215585-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215585-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215585-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215585-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215585-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215585-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215585-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215585-001	AB	1	`a50c72e98297…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2892-3	2025-01-30	C162847	48780-1	2cef2736-a46d-d83d-e063-dadaa90ab31f	Diclofenac Potassium Tablets USP, 50 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2892-3	Diclofenac Potassium	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2892	DICLOFENAC POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	3	Legacy NDC, 1 package rows	20231007_eec7c048-55f8-52b2-e053-2a95a90a95c5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	REMEDYREPACK INC.	c4976d69-ca06-4263-9240-6fd8b44a9b6d	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215585 application number: ANDA215585
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	e29e7aea-0bcd-46e5-b011-fbaf5aa2244a	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215585 application number: ANDA215585
Diclofenac Potassium	DICLOFENAC POTASSIUM	AvKARE	21dc9953-4e6d-50f0-e063-6294a90ac4ef	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215585 application number: ANDA215585
Diclofenac Potassium	DICLOFENAC POTASSIUM	Ingenus Pharmaceuticals, LLC	6926444f-0dca-4aeb-812e-755a83b149f4	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215585 application number: ANDA215585
Diclofenac Potassium	DICLOFENAC POTASSIUM	Preferred Pharmaceuticals Inc.	4f482f98-ef10-45d7-8e9f-9cf291d93092	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215585 application number: ANDA215585

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	eec7c048-55f8-52b2-e053-2a95a90a95c5	3
855942	diclofenac potassium 50 MG Oral Tablet	SCD	eec7c048-55f8-52b2-e053-2a95a90a95c5	3
855942	Diclofenac K+ 50 MG Oral Tablet	SY	eec7c048-55f8-52b2-e053-2a95a90a95c5	3
855942	Diclofenac Pot 50 MG Oral Tablet	SY	eec7c048-55f8-52b2-e053-2a95a90a95c5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2892-3	68071289203	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2892-3)	2022-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Potassium Tablets USP, 50 mg Rx only Prescribing Information	NuCare Pharmaceuticals,Inc.	2023-10-06	HUMAN PRESCRIPTION DRUG LABEL	3