Diclofenac Sodium

Product NDC: 63187-761
11-digit product format: 631870761
Labeler code: 63187
Product ID: 63187-761_e6961030-ff60-458f-9576-387b97ff2a48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA074514
Marketing category: ANDA
Marketing start: 1996-03-26
Substance: DICLOFENAC SODIUM
Active strength: 75 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074514-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB		1996-03-26
A074514-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		1996-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074514-001	AB
A074514-002	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 3 · 82 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	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A074514-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074514-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074514-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074514-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074514-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074514-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074514-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074514-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074514-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074514-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074514-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074514-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074514-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074514-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074514-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074514-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074514-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074514-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855926	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
77c3cb56-c071-4d92-a0d6-022417a27de4	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	SPL version
63187-761-15	Diclofenac Sodium	15 in 1 BOTTLE	TABLET, DELAYED RELEASE	15	3
63187-761-30	Diclofenac Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	3
63187-761-60	Diclofenac Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	3
63187-761-90	Diclofenac Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-761-15	EA - Each	63187-761	7f9a491f-d0bf-4fae-97eb-f0641974c062	1	2017-05-04
63187-761-30	EA - Each	63187-761	89a84315-b288-4f5a-9dd3-97f8fcfb4b38	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-761	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 4 package rows	20191121_77c3cb56-c071-4d92-a0d6-022417a27de4.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	c1d87003-f54b-4381-9e11-1c39ea2d9eb3	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	663a3dbc-a631-4046-8852-ec619c41c81d	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	47793dca-5e9e-44ee-8e66-5e42e1831b1e	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	b74be49d-74ff-491b-962b-0edd3a57cbc9	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	87d5a720-f154-4c4b-b2d4-0ae58455dda0	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	f5b4e308-c156-4865-95ee-1a8e267535ba	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Actavis Pharma, Inc.	a57b897e-0cbe-4ac3-969f-b00357a0cfa8	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	77c3cb56-c071-4d92-a0d6-022417a27de4	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514 ndc (product): 63187-761
Diclofenac Sodium	DICLOFENAC SODIUM	Aphena Pharma Solutions - Tennessee, LLC	e4af374a-1281-46af-a0a9-48820db6c947	2018-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	77c3cb56-c071-4d92-a0d6-022417a27de4	3
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	77c3cb56-c071-4d92-a0d6-022417a27de4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-761-15	63187076115	15 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-15)	2017-01-02	0000-00-00	No	No	Current
63187-761-30	63187076130	30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-30)	2016-10-03	0000-00-00	No	No	Current
63187-761-60	63187076160	60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-60)	2016-10-03	0000-00-00	No	No	Current
63187-761-90	63187076190	90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-90)	2016-10-03	0000-00-00	No	No	Current