Diclofenac Potassium

Product NDC: 67296-1316
11-digit product format: 672961316
Labeler code: 67296
Product ID: 67296-1316_d61127a3-34eb-8104-e053-2995a90a8bcb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA075219
Marketing category: ANDA
Marketing start: 1998-08-11
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	67296-1316		I	Inactivated by FDA		2026-08-11
excluded package	package	67296-1316	67296-1316-5	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 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
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1316-5	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1316-5	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1316-5	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1316-5	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1316-5	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A075219-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075219-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075219-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075219-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075219-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075219-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075219-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075219-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075219-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075219-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075219-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075219-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075219-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075219-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075219-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075219-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075219-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075219-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075219-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075219-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075219-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075219-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075219-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075219-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075219-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075219-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075219-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075219-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075219-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075219-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075219-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075219-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075219-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075219-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075219-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075219-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075219-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075219-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075219-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075219-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075219-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075219-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
67296-1316-5	2024-07-17	C162847	48780-1	1030e365-4108-111a-e063-dadaa90a10e2	4fe592cf-b5ac-3d3c-e054-00144ff8d46c
67296-1316-5	2024-01-30	C162847	48780-1	1030e365-4108-111a-e063-dadaa90a10e2	4fe592cf-b5ac-3d3c-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1316-5	Diclofenac Potassium	15 in 1 BOTTLE	TABLET, FILM COATED	15		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1316	DICLOFENAC POTASSIUM TABLET, FILM COATED [REDPHARM DRUG, INC.]	4	Legacy NDC, 1 package rows	20240718_4fe592cf-b5ac-3d3c-e054-00144ff8d46c.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	Preferred Pharmaceuticals Inc.	8dfaa874-d6cf-4107-b57f-25dab02aa201	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219
Diclofenac Potassium	DICLOFENAC POTASSIUM	PD-Rx Pharmaceuticals, Inc.	08e41a9d-644c-4ac6-aba3-38d7c3f36d36	2025-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219
Diclofenac Potassium	DICLOFENAC POTASSIUM	Teva Pharmaceuticals USA, Inc.	77b60a0c-e49a-4ad4-abb1-b662c24ab782	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219
Diclofenac Potassium	DICLOFENAC POTASSIUM	NuCare Pharmaceuticals, Inc.	3da9e463-1b2f-54c0-e054-00144ff88e88	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	717341fc-e067-0005-215c-053f6d12e0d1	2023-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219

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	4fe592cf-b5ac-3d3c-e054-00144ff8d46c	4
855942	diclofenac potassium 50 MG Oral Tablet	SCD	4fe592cf-b5ac-3d3c-e054-00144ff8d46c	4
855942	Diclofenac K+ 50 MG Oral Tablet	SY	4fe592cf-b5ac-3d3c-e054-00144ff8d46c	4
855942	Diclofenac Pot 50 MG Oral Tablet	SY	4fe592cf-b5ac-3d3c-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1316-5	67296131605	15 TABLET, FILM COATED in 1 BOTTLE (67296-1316-5)	1998-08-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Potassium - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	4