Diclofenac Sodium D/R

Product NDC: 61919-074
Requested package NDC: 61919-074-90
11-digit product format: 619190074
Labeler code: 61919
Product ID: 61919-074_c42fea0c-d812-061c-e053-2995a90a9b8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium D/R
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Direct RX
Application: ANDA075185
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-074	61919-074-90	U	Excluded because listing certification expired		2026-08-03

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075185-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13
A075185-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13
A075185-003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075185-001	AB
A075185-002	AB
A075185-003	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 4 · 123 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	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-002	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-003	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075185-001	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-11-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075185-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075185-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075185-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075185-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075185-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075185-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075185-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075185-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075185-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075185-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075185-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075185-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075185-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075185-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075185-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075185-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075185-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075185-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075185-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075185-001	AB	1	`8072bd15b7f6…`

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
61919-074-30	Diclofenac Sodium D/R	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	12
61919-074-60	Diclofenac Sodium D/R	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	12
61919-074-90	Diclofenac Sodium D/R	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-074-30	EA - Each	61919-074	505cd5bd-cfcc-4c42-9717-cc950a568d55	1	2014-05-02
61919-074-60	EA - Each	61919-074	0fd373e1-6e4d-41b6-94ac-6cd581de0d52	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
POLYETHYLENE GLYCOL 2000	INACTIVE INGREDIENT	HAF0412YIT	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-074	DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]	12	Legacy NDC, 3 package rows	20230408_2ae3c1e2-f053-4efb-9597-eeac4998d23f.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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	ddd2278b-70be-41ca-8a84-e3fe0f1a1561	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	30c7e4fd-30af-4d28-a6ef-7386ff83cfb8	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	10991fe6-fafd-49af-9684-83b447c19c67	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium D/R	DICLOFENAC SODIUM D/R	DirectRx	50886f90-8cd0-4d38-e063-6294a90a44e4	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	7e940ce5-0f82-4d07-b507-c644481879c1	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	e947653c-6789-4c15-82c9-4b1402f6d6ac	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Redpharm Drug	4cd2e51b-2019-6eb6-e063-6294a90ad7ef	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	0cefb675-c54e-44eb-b35c-38354b77eddd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	74011b00-7e2e-40a7-ab30-c05a20559814	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	468fab22-2b69-4a2c-e063-6294a90aab9a	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium	DICLOFENAC SODIUM	AvKARE	19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	REMEDYREPACK INC.	14c1b1a1-bc06-4722-9612-e88ae52272bc	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	c16e7e43-3869-9fef-e053-2995a90a1fdb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Northwind Health Company, LLC	f2b7ea75-738b-54a8-e053-2995a90a00d5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	47a7a294-55bb-8d19-e063-6394a90a5440	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	40388047-7fbe-49bf-bed8-e5087bed4e03	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	4a88f136-f7c7-47d7-b85d-8a2f9f118f09	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	58063c26-86fe-4f03-97ef-51706e5f4054	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	4539e9e7-5d82-3b36-e063-6394a90a1396	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	b8072af2-9940-4827-9fbd-de46ad8bf929	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075185 application number: ANDA075185

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	2ae3c1e2-f053-4efb-9597-eeac4998d23f	12
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	2ae3c1e2-f053-4efb-9597-eeac4998d23f	12
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	2ae3c1e2-f053-4efb-9597-eeac4998d23f	12
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	2ae3c1e2-f053-4efb-9597-eeac4998d23f	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-074-90	61919007490	90 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-074-90)	2014-01-01	0000-00-00	No	No	Current