Diclofenac Sodium

Product NDC: 70518-2673
Requested package NDC: 70518-2673-0
11-digit product format: 705182673
Labeler code: 70518
Product ID: 70518-2673_d6e40617-1105-4cdf-e053-2995a90a436f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: GEL
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA209484
Marketing category: ANDA
Marketing start: 2020-04-07
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 10 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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2673	70518-2673-0	D	Discontinued by firm		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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A209484-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2018-11-21

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	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209484-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-11-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A209484-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209484-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209484-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209484-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209484-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209484-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209484-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209484-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209484-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209484-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209484-001	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-11-25	These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988
2024-01-30	These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988
2022-01-31	These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988
2022-01-28	These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2673-0	GM - Gram	70518-2673	f95fa1a1-2fc2-4a47-b47b-7e99b6c6ec8f	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2673	DICLOFENAC SODIUM GEL [REMEDYREPACK INC.]	4	Legacy NDC	20220201_35f52a3c-6e79-40c1-91db-0db4335b20d9.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2673-0	70518267300	1 TUBE in 1 CARTON (70518-2673-0) > 100 g in 1 TUBE	1 tube	2020-04-07	0000-00-00	No	No	Current