Diclofenac Sodium

Product NDC: 43063-270
11-digit product format: 430630270
Labeler code: 43063
Product ID: 43063-270_7d3def63-eb42-642f-e053-2a91aa0adbc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA076152
Marketing category: ANDA
Marketing start: 2002-02-15
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: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-270		D	Discontinued by firm	2026-10-05
excluded package	package	43063-270	43063-270-30	D	Discontinued by firm	2026-10-05
excluded package	package	43063-270	43063-270-60	D	Discontinued by firm	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 1 · 36 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	43063-270-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-270-30	`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	43063-270-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-270-30	`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	43063-270-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-270-30	`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	43063-270-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-270-30	`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	43063-270-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-270-30	`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	43063-270-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-270-30	`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	43063-270-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-270-30	`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	43063-270-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-270-30	`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	43063-270-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-270-30	`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	43063-270-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-270-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-270-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-270-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-270-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-270-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076152-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076152-001	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.

Product history page 1 of 2 · 43 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
2026-09-14 22:38:34	2026-08	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2001-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2001-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`f41ea6bd6efb…`

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	A076152-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076152-001	AB	1	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-270-30	EA - Each	43063-270	9956f587-d8a1-4a91-aee8-6a6c16c2ecd4	1	2012-07-24
43063-270-60	EA - Each	43063-270	823de383-d418-46f5-8eba-0a7bceb49bb3	1	2013-05-02

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	d9b6f1d0-1710-46fb-8ea4-80b3ca60a575	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076152 application number: ANDA076152