Diclofenac Sodium

Product NDC: 0378-6280
11-digit product format: 003786280
Labeler code: 0378
Product ID: 0378-6280_a6f20b0b-84e7-44d8-982c-e93ea4509e9e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA075281
Marketing category: ANDA
Marketing start: 2010-05-18
Marketing end: 2020-09-30
Substance: DICLOFENAC SODIUM
Active strength: 50 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: 0000-00-00
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	0378-6280		D	Discontinued by firm	2026-08-11
excluded package	package	0378-6280	0378-6280-01	D	Discontinued by firm	2026-08-11
excluded package	package	0378-6280	0378-6280-10	D	Discontinued by firm	2026-08-11

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	0378-6280-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-6280-10	`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	0378-6280-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-6280-10	`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	0378-6280-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-6280-10	`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	0378-6280-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-6280-10	`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	0378-6280-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-6280-10	`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	0378-6280-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-6280-10	`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	0378-6280-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-6280-10	`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	0378-6280-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-6280-10	`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	0378-6280-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-6280-10	`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	0378-6280-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-6280-10	`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	0378-6280-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-6280-10	`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	0378-6280-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-6280-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6280-01	EA - Each	0378-6280	53c0fb45-cfef-4064-ab13-38d45fabf4d9	1	2012-07-24
0378-6280-10	EA - Each	0378-6280	ce217861-067a-43e1-bfbd-b3a0f1bdd2f8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC]	4
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]	3

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
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
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	2d92077c-75d2-4b34-8704-71660f77a63b	4
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	2d92077c-75d2-4b34-8704-71660f77a63b	4
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	2d92077c-75d2-4b34-8704-71660f77a63b	4
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	2d92077c-75d2-4b34-8704-71660f77a63b	4

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium - Mylan Institutional Inc.	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	8
Diclofenac Sodium - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2016-05-26	HUMAN PRESCRIPTION DRUG LABEL	11
DICLOFENAC SOD DR	STAT Rx USA LLC \| PSS World Medical Inc.	2012-02-21	HUMAN PRESCRIPTION DRUG LABEL	4