DICLOFENAC SODIUM

Product NDC: 82868-114
Requested package NDC: 82868-114-30
11-digit product format: 828680114
Labeler code: 82868
Product ID: 82868-114_5990259d-2f91-20d3-e063-6394a90a3d23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICLOFENAC SODIUM
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA075281
Marketing category: ANDA
Marketing start: 2026-08-17
Substance: DICLOFENAC SODIUM
Active strength: 75 mg/1
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075281-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB		2002-02-12
A075281-003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		2002-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075281-002	AB
A075281-003	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 3 · 86 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	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	2002-02-12	`74a2ff9319b5…`

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	A075281-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075281-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075281-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075281-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075281-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075281-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075281-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075281-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075281-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075281-003	AB	1	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	A075281-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075281-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075281-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075281-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075281-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075281-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075281-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075281-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075281-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075281-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: DICLOFENAC SODIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855926	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5990259d-2f90-20d3-e063-6394a90a3d23	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	5a852412-69af-6502-e063-6294a90a0748	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Northwind Health Company, LLC	5990259d-2f90-20d3-e063-6394a90a3d23	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281 ndc (package): 82868-114-30 ndc (product): 82868-114 ndc11 (package): 82868011430
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Northwind Health Company, LLC	4dde6e36-7540-1cc3-e063-6294a90a3941	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	6e6a6f98-5517-4f67-9a6a-71019ba2d773	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	f92576d7-3ad9-43a3-8b10-3a29fbf712a4	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	6c57e330-ebbe-4165-84a8-4844b2f0097e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	3487033c-7c62-4034-8718-73a7c49b26a0	2025-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075281 application number: ANDA075281

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	Sample	Exclude flag	Status
82868-114-30	82868011430	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-114-30)	2026-08-17	No	No	Current