Diclofenac Sodium

Product NDC: 45865-964
11-digit product format: 458650964
Labeler code: 45865
Product ID: 45865-964_9aefc063-74ab-7ccb-e053-2995a90a6706
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION
Route: TOPICAL
Labeler: medsource pharmaceuticals
Application: ANDA202769
Marketing category: ANDA
Marketing start: 2015-11-04
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 16 mg/mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-964		I	Inactivated by FDA		2026-08-03
excluded package	package	45865-964	45865-964-01	I	Inactivated by FDA		2026-08-03

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-964-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-964-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-964-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-964-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-964-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-964-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-964-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-964-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-964-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A202769-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2015-07-08

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	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2015-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202769-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-07-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202769-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202769-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202769-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202769-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202769-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202769-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202769-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202769-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202769-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202769-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202769-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202769-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202769-001	AT	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202769-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202769-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202769-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202769-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202769-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202769-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202769-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202769-001	AT	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-964-01	2025-01-30	C162847	48780-1	2cef2736-b603-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Diclofenac Sodium Topical Solution safely and effectively. See full prescribing information for Diclofenac Sodium Topical Solution. DICLOFENAC Sodium Topical Solution 1.5% w/w is for topical use only. Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-964-01	Diclofenac Sodium	150 mL in 1 BOTTLE	SOLUTION	150		1
45865-964-01	Diclofenac Sodium	1 in 1 CARTON	SOLUTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-964	DICLOFENAC SODIUM SOLUTION [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 2 package rows	20191231_9aefa19d-8644-2314-e053-2a95a90a130a.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 Sodium	DICLOFENAC SODIUM	Quality Care Products LLC	94422b85-28ed-477f-853a-71d1d6cf17d5	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202769 application number: ANDA202769
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	7bc185e2-e749-4a24-8550-c2f6d39222d2	2020-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202769 application number: ANDA202769

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
857700	diclofenac sodium 1.5 % Topical Solution	PSN	9aefa19d-8644-2314-e053-2a95a90a130a	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	9aefa19d-8644-2314-e053-2a95a90a130a	1
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	9aefa19d-8644-2314-e053-2a95a90a130a	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	9aefa19d-8644-2314-e053-2a95a90a130a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-964-01	45865096401	1 BOTTLE in 1 CARTON (45865-964-01) > 150 mL in 1 BOTTLE	1 bottle	2019-12-11	0000-00-00	No	No	Current