DICLOFENAC SODIUM

Product NDC: 50090-7855
Requested package NDC: 50090-7855-4
11-digit product format: 500907855
Labeler code: 50090
Product ID: 50090-7855_7cd367ac-9d03-4db9-9c8e-1d8dc26aee35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICLOFENAC SODIUM
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075281
Marketing category: ANDA
Marketing start: 2025-04-17
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 1.

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 · 82 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	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…`
2022-03-09 01:35 UTC	2022-03	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075281-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075281-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL		2002-02-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`

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
6c57e330-ebbe-4165-84a8-4844b2f0097e	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-7855-0	DICLOFENAC SODIUM	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100	1
50090-7855-1	DICLOFENAC SODIUM	20 in 1 BOTTLE	TABLET, DELAYED RELEASE	20	1
50090-7855-2	DICLOFENAC SODIUM	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	1
50090-7855-3	DICLOFENAC SODIUM	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	1
50090-7855-4	DICLOFENAC SODIUM	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	1
50090-7855-8	DICLOFENAC SODIUM	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	1
50090-7855-9	DICLOFENAC SODIUM	180 in 1 BOTTLE	TABLET, DELAYED RELEASE	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7855-0	EA - Each	50090-7855	4b4bfc14-3299-433a-a838-4dd1015d0746	1	2026-02-05
50090-7855-1	EA - Each	50090-7855	911459d4-d251-4b22-b120-a0690db37340	1	2026-02-05
50090-7855-2	EA - Each	50090-7855	34235b0e-c88d-480a-aadf-f1db18cbec7f	1	2026-02-05
50090-7855-3	EA - Each	50090-7855	f8249f51-a697-47dd-aa8e-d5ae1f36d975	1	2026-02-05
50090-7855-4	EA - Each	50090-7855	8c4db7f0-2cc0-4659-bab4-1b8bd9979b78	1	2026-02-05
50090-7855-8	EA - Each	50090-7855	bc216f61-f0bc-4268-8331-3dba701442de	1	2026-02-05
50090-7855-9	EA - Each	50090-7855	5e809301-3d6c-4445-b25a-d20dddcc10ec	1	2026-02-05

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Northwind Health Company, LLC	4dde6e36-7540-1cc3-e063-6294a90a3941	2026-02-12	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 ndc (package): 50090-7855-4 ndc (product): 50090-7855 ndc11 (package): 50090785504
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	6c57e330-ebbe-4165-84a8-4844b2f0097e	1
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	6c57e330-ebbe-4165-84a8-4844b2f0097e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7855-4	50090785504	60 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-4)	2026-01-14	No	No	Current