Diclofenac Potassium

Product NDC: 59651-353
Requested package NDC: 59651-353-11
11-digit product format: 596510353
Labeler code: 59651
Product ID: 59651-353_69669299-a982-4891-9374-bfa88823c5f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Potassium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA213875
Marketing category: ANDA
Marketing start: 2022-03-14
Substance: DICLOFENAC POTASSIUM
Active strength: 25 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	59651-353	59651-353-11	UNFINISHED	Active or certified unfinished drug listing		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 · 15 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
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`

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
A213875-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB		2021-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213875-001	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	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213875-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2021-10-19	`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	A213875-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213875-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213875-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213875-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213875-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213875-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213875-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213875-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213875-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213875-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213875-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213875-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213875-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213875-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213875-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213875-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213875-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213875-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213875-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213875-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213875-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213875-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213875-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213875-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213875-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213875-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213875-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213875-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213875-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213875-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213875-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213875-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213875-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213875-001	AB	1	`a50c72e98297…`

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	25 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
858342	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
7efdbe23-503a-4f38-a0b6-c003033f0de7	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-353-01	Diclofenac Potassium	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		4
59651-353-08	Diclofenac Potassium	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-353-08	EA - Each	59651-353	d42e9a3d-0d0d-45fe-96e2-89e5fb151ab1	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-353	DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED [AUROBINDO PHARMA LIMITED]	4	Current NDC, Legacy NDC, 2 package rows	20241215_7efdbe23-503a-4f38-a0b6-c003033f0de7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	Aurobindo Pharma Limited	7efdbe23-503a-4f38-a0b6-c003033f0de7	2024-12-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213875 application number: ANDA213875 ndc (product): 59651-353

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
858342	diclofenac potassium 25 MG Oral Capsule	PSN	7efdbe23-503a-4f38-a0b6-c003033f0de7	4
858342	diclofenac 25 MG Oral Capsule	SCD	7efdbe23-503a-4f38-a0b6-c003033f0de7	4
858342	diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral Capsule	SY	7efdbe23-503a-4f38-a0b6-c003033f0de7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
59651-353-11	59651035311	1000 CAPSULE, LIQUID FILLED in 1 BAG (59651-353-11)	14-MAR-22	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Potassium	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2024-12-07	Human Prescription Drug Label	4