Diclofenac Sodium

Product NDC: 87063-223
11-digit product format: 870630223
Labeler code: 87063
Product ID: 87063-223_53e28a98-5804-b759-e063-6294a90a219a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION
Route: TOPICAL
Labeler: ASCLEMED USA INC.
Application: ANDA208021
Marketing category: ANDA
Marketing start: 2024-02-19
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
53e8ad44-ff67-d3bb-e063-6394a90a524d	Available on FDA.report

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 ndc (product): 87063-223
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
87063-223-04	87063022304	1 BOTTLE, PUMP in 1 CARTON (87063-223-04) / 112 g in 1 BOTTLE, PUMP	2026-06-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	1