Diclofenac Potassium

Product NDC: 66267-070
Requested package NDC: 66267-070-60
11-digit product format: 662670070
Labeler code: 66267
Product ID: 66267-070_1f98d6d5-cf08-a2bf-e063-6294a90a370b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA075219
Marketing category: ANDA
Marketing start: 1998-08-11
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: 2026-12-31
Current FDA listing: Yes

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 42 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
2026-08-18 06:07:40	2026-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A075219-001	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Potassium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC POTASSIUM	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L4D5UA6CB4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855942	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3da9e463-1b2f-54c0-e054-00144ff88e88	Available on FDA.report

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, Related label table
NDC	Effective	Related label
66267-070-30	2024-08-13	DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only
66267-070-60	2024-08-13	DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only
66267-070-30	2023-01-30	DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only
66267-070-60	2023-01-30	DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66267-070-30	Diclofenac Potassium	30 in 1 BOTTLE	TABLET, FILM COATED	30		4
66267-070-60	Diclofenac Potassium	60 in 1 BOTTLE	TABLET, FILM COATED	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66267-070-30	EA - Each	66267-070	5e2b6314-86a1-40b4-8891-66c9cd85ac2e	1	2016-10-06
66267-070-60	EA - Each	66267-070	de2b2d34-3059-4c17-8aa8-7d4aa21293c9	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66267-070	DICLOFENAC POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240815_3da9e463-1b2f-54c0-e054-00144ff88e88.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 ndc (package): 66267-070-60 ndc (product): 66267-070 ndc11 (package): 66267007060
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	3da9e463-1b2f-54c0-e054-00144ff88e88	4
855942	diclofenac potassium 50 MG Oral Tablet	SCD	3da9e463-1b2f-54c0-e054-00144ff88e88	4
855942	Diclofenac K+ 50 MG Oral Tablet	SY	3da9e463-1b2f-54c0-e054-00144ff88e88	4
855942	Diclofenac Pot 50 MG Oral Tablet	SY	3da9e463-1b2f-54c0-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66267-070-60	66267007060	60 TABLET, FILM COATED in 1 BOTTLE (66267-070-60)	2016-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only	NuCare Pharmaceuticals, Inc.	2024-08-13	HUMAN PRESCRIPTION DRUG LABEL	4