Diclofenac potassium

Product NDC: 63629-4871
11-digit product format: 636294871
Labeler code: 63629
Product ID: 63629-4871_3fab7fe9-7231-43f6-a275-5eca58ca7150
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac potassium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204648
Marketing category: ANDA
Marketing start: 2022-03-24
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

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
A204648-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB		2016-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204648-001	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	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204648-001	DICLOFENAC POTASSIUM	25MG	CAPSULE / ORAL	AB	2016-02-23	`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	A204648-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204648-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204648-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204648-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204648-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204648-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204648-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204648-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204648-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204648-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204648-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204648-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204648-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204648-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204648-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204648-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204648-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204648-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204648-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204648-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204648-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204648-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204648-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204648-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204648-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204648-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204648-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204648-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204648-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204648-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204648-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204648-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204648-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204648-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204648-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204648-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204648-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204648-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204648-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204648-001	AB	1	`cb3db0bc1861…`

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
8c54e404-2dbd-49cd-8235-b2a708bae563	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
63629-4871-1	Diclofenac potassium	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-4871	DICLOFENAC POTASSIUM CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	1	Current NDC, 1 package rows	20250119_8c54e404-2dbd-49cd-8235-b2a708bae563.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac potassium	DICLOFENAC POTASSIUM	TEVA PHARMACEUTICALS, INC.	d9685883-9d0b-81da-e053-2a95a90ab8d8	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204648 application number: ANDA204648
Diclofenac potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	8c54e404-2dbd-49cd-8235-b2a708bae563	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204648 application number: ANDA204648 ndc (product): 63629-4871

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	8c54e404-2dbd-49cd-8235-b2a708bae563	1
858342	diclofenac 25 MG Oral Capsule	SCD	8c54e404-2dbd-49cd-8235-b2a708bae563	1
858342	diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral Capsule	SY	8c54e404-2dbd-49cd-8235-b2a708bae563	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63629-4871-1	63629487101	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-4871-1)	2025-01-17	No	No	Current