Diclofenac Sodium

Product NDC: 60760-264
11-digit product format: 607600264
Labeler code: 60760
Product ID: 60760-264_7a8055b3-aa1b-346c-e053-2a91aa0a4a16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA075492
Marketing category: ANDA
Marketing start: 2018-05-08
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: 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	60760-264		D	Discontinued by firm		2026-08-17
excluded package	package	60760-264	60760-264-30	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075492-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075492-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075492-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-02-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075492-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075492-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075492-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075492-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075492-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075492-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075492-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075492-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075492-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075492-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075492-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075492-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075492-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075492-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075492-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075492-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075492-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075492-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075492-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075492-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075492-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075492-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075492-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075492-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075492-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075492-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075492-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075492-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075492-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075492-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075492-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075492-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075492-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075492-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075492-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075492-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075492-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075492-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075492-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075492-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-264-30	EA - Each	60760-264	821aca74-3500-4c69-b592-7ab025e5aa11	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-264	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]	2	Legacy NDC	20181114_6bb7c6fb-ac44-764c-e053-2991aa0a3b60.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Oceanside Pharmaceuticals	c48113e0-9f1e-4086-b18f-3204c0d2a689	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	d70fcd8e-a72b-41ef-ac26-e0f2f279f062	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	49013aad-475c-4efb-84c6-15a5d4664fbf	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492
Diclofenac Sodium ER	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	ecaa39b8-067c-80d7-e053-2a95a90a7354	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	abacf60f-0410-e6da-e053-2995a90a413c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	d9698809-4887-4514-aa28-0066355ef908	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075492 application number: ANDA075492

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	Marketing end	Sample	Exclude flag	Status
60760-264-30	60760026430	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-264-30)	2018-05-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Extended-release Tablets	St. Mary's Medical Park Pharmacy \| Valeant Pharmaceuticals International, Inc.	2018-11-12	HUMAN PRESCRIPTION DRUG LABEL	2