Diclofenac Sodium

Product NDC: 68788-8743
11-digit product format: 687888743
Labeler code: 68788
Product ID: 68788-8743_f09a5fd7-e548-477e-9458-5a7cf578e8e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA208021
Marketing category: ANDA
Marketing start: 2024-09-26
Substance: DICLOFENAC SODIUM
Active strength: 20 mg/g
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208021-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208021-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2022-09-20	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208021-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	RS	2022-09-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208021-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208021-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208021-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208021-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208021-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208021-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208021-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208021-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208021-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208021-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208021-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208021-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208021-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208021-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208021-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208021-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208021-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208021-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208021-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208021-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208021-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208021-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208021-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208021-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208021-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208021-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208021-001	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208021-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	20 mg/g

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
1487074	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
e042e64c-5f18-4483-bcbd-dfd9b08a81cf	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
68788-8743-1	Diclofenac Sodium	1 in 1 CARTON	SOLUTION	1		4
68788-8743-1	Diclofenac Sodium	112 g in 1 BOTTLE, PUMP	SOLUTION	112		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8743-1	GM - Gram	68788-8743	021f5e62-ce54-4981-8faf-7cd8c092c073	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8743	DICLOFENAC SODIUM SOLUTION [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 2 package rows	20250322_e042e64c-5f18-4483-bcbd-dfd9b08a81cf.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	ASCLEMED USA INC.	53e8ad44-ff67-d3bb-e063-6394a90a524d	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208021 application number: ANDA208021
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	e042e64c-5f18-4483-bcbd-dfd9b08a81cf	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208021 application number: ANDA208021 ndc (product): 68788-8743
Diclofenac Sodium Topical Solution	DICLOFENAC SODIUM TOPICAL SOLUTION	Direct_Rx	223f0fb4-2006-c2dd-e063-6394a90a563a	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208021 application number: ANDA208021
Diclofenac Sodium	DICLOFENAC SODIUM	Lupin Pharmaceuticals, Inc.	609c5344-9c97-4fa8-ad53-d0f622ce64ec	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208021 application number: ANDA208021
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	3a4f7301-aa1c-9064-e063-6294a90a6eb4	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208021 application number: ANDA208021
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	898558e7-17f8-40cd-9dfc-67ddd64a5a42	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208021 application number: ANDA208021
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	1be247b8-dafd-ddf9-e063-6294a90aa9e1	2024-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208021 application number: ANDA208021

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
1487074	diclofenac sodium 2 % Topical Solution	PSN	e042e64c-5f18-4483-bcbd-dfd9b08a81cf	4
1487074	diclofenac sodium 20 MG/ML Topical Solution	SCD	e042e64c-5f18-4483-bcbd-dfd9b08a81cf	4
1487074	diclofenac sodium 2 % Topical Solution	SY	e042e64c-5f18-4483-bcbd-dfd9b08a81cf	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-8743-1	68788874301	1 BOTTLE, PUMP in 1 CARTON (68788-8743-1) / 112 g in 1 BOTTLE, PUMP	2024-09-26	No	No	Current