Diclofenac Sodium

Product NDC: 45865-364
11-digit product format: 458650364
Labeler code: 45865
Product ID: 45865-364_f4dc2502-bb11-4c1d-a67d-67ea7785749c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA075910
Marketing category: ANDA
Marketing start: 2009-01-05
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 100 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-364		I	Inactivated by FDA	2026-10-05
excluded package	package	45865-364	45865-364-15	I	Inactivated by FDA	2026-10-05
excluded package	package	45865-364	45865-364-30	I	Inactivated by FDA	2026-10-05
excluded package	package	45865-364	45865-364-49	I	Inactivated by FDA	2026-10-05
excluded package	package	45865-364	45865-364-60	I	Inactivated by FDA	2026-10-05
excluded package	package	45865-364	45865-364-90	I	Inactivated by FDA	2026-10-05

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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-364-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-364-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-364-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-364-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-364-49	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-364-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-364-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-364-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-364-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-364-49	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-364-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-364-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-364-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-364-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-364-49	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-364-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-364-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-364-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-364-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-364-49	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-364-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-364-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-364-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-364-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-364-49	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-364-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-364-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-364-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-364-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-364-49	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-364-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-364-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-364-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-364-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-364-49	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-364-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-364-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-364-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-364-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-364-49	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-364-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-364-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-364-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-364-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-364-49	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-364-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-364-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-364-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-364-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-364-49	`ad56d346431e…`	`cc804d4bbf1e…`

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
A075910-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL			2002-01-07

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

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, Related label table
NDC	Related label
45865-364-15	DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
45865-364-30	DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
45865-364-49	DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
45865-364-60	DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
45865-364-90	DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45865-364-15	Diclofenac SodiumExtended-Release	15 in 1 BOTTLE	TABLET, EXTENDED RELEASE	15	2
45865-364-30	Diclofenac SodiumExtended-Release	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	2
45865-364-49	Diclofenac SodiumExtended-Release	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	2
45865-364-60	Diclofenac SodiumExtended-Release	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	2
45865-364-90	Diclofenac SodiumExtended-Release	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-364	DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 5 package rows	20120801_d349b4ca-3aec-44a8-a4d5-87be4c822190.zip

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
855657	diclofenac sodium 100 MG 24HR Extended Release Oral Tablet	PSN	d349b4ca-3aec-44a8-a4d5-87be4c822190	2
855657	24 HR diclofenac sodium 100 MG Extended Release Oral Tablet	SCD	d349b4ca-3aec-44a8-a4d5-87be4c822190	2
855657	diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet	SY	d349b4ca-3aec-44a8-a4d5-87be4c822190	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45865-364-15	45865036415	15 in 1 BOTTLE	Historical
45865-364-30	45865036430	30 in 1 BOTTLE	Historical
45865-364-49	45865036449	100 in 1 BOTTLE	Historical
45865-364-60	45865036460	60 in 1 BOTTLE	Historical
45865-364-90	45865036490	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP	Medsource Pharmaceuticals	2012-07-24	HUMAN PRESCRIPTION DRUG LABEL	2