DICLOFENAC SODIUM

Product NDC: 61919-838
Requested package NDC: 61919-838-60
11-digit product format: 619190838
Labeler code: 61919
Product ID: 61919-838_9c93a06e-b8d1-4079-e053-2a95a90ac067
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICLOFENAC SODIUM
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: DIRECT RX
Application: ANDA075910
Marketing category: ANDA
Marketing start: 2014-01-01
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: 2021-12-31
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	61919-838	61919-838-60	I	Inactivated by FDA		2026-10-05

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

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
A075910-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL			2002-01-07

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075910-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2002-01-07	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-838-30	2023-01-30	C162847	48780-1	f386c649-f393-0266-e053-dadaa90a7c1a	DICLOFENAC SODIUM
61919-838-60	2023-01-30	C162847	48780-1	f386c649-f393-0266-e053-dadaa90a7c1a	DICLOFENAC SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-838-30	DICLOFENAC SODIUM	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		3
61919-838-60	DICLOFENAC SODIUM	60 in 1 PACKAGE	TABLET, FILM COATED, EXTENDED RE	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-838-30	EA - Each	61919-838	956deaed-b793-4d62-adab-44775260580a	1	2015-10-02
61919-838-60	EA - Each	61919-838	a29538d4-335e-44ef-ae27-f53fa3a14a55	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-838	DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]	3	Legacy NDC, 2 package rows	20200128_74bb5cb3-03e0-4dbf-9b8a-f67417538e4f.zip

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
855657	diclofenac sodium 100 MG 24HR Extended Release Oral Tablet	PSN	74bb5cb3-03e0-4dbf-9b8a-f67417538e4f	3
855657	24 HR diclofenac sodium 100 MG Extended Release Oral Tablet	SCD	74bb5cb3-03e0-4dbf-9b8a-f67417538e4f	3
855657	diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet	SY	74bb5cb3-03e0-4dbf-9b8a-f67417538e4f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-838-60	61919083860	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (61919-838-60)	2014-01-01	0000-00-00	No	No	Current