Diclofenac Sodium

Product NDC: 68788-8193
11-digit product format: 687888193
Labeler code: 68788
Product ID: 68788-8193_403085a5-446c-4796-aaf1-64be07a98c9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA077863
Marketing category: ANDA
Marketing start: 2022-05-16
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077863-003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077863-003	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		2007-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		2007-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		2007-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077863-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2007-06-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A077863-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077863-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077863-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077863-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077863-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077863-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077863-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077863-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077863-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077863-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077863-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077863-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077863-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077863-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077863-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077863-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077863-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077863-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077863-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077863-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077863-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077863-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077863-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077863-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077863-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077863-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077863-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077863-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077863-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077863-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077863-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077863-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077863-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077863-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077863-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077863-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077863-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077863-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077863-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077863-003	AB	1	`cb3db0bc1861…`

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
ed1b5ec7-2812-4a81-90d1-953baa0b0ec8	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
68788-8193-1	Diclofenac Sodium	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100	5
68788-8193-3	Diclofenac Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	5
68788-8193-6	Diclofenac Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	5
68788-8193-8	Diclofenac Sodium	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	5
68788-8193-9	Diclofenac Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8193-1	EA - Each	68788-8193	2425fb44-0ebb-43d3-b73a-5be947fa7f1f	1	2022-07-06
68788-8193-3	EA - Each	68788-8193	944ce989-149f-4e8f-a4b7-be16aa21520d	1	2022-07-06
68788-8193-6	EA - Each	68788-8193	cf4a944b-d0de-47ef-a42d-b205d211dc8a	1	2022-07-06
68788-8193-8	EA - Each	68788-8193	8eb61b0c-6bbe-40ea-8e39-aa53446c8878	1	2022-07-06
68788-8193-9	EA - Each	68788-8193	2931a5f5-dbdc-4ce3-b079-ad5a23c0b5a2	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8193	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 5 package rows	20250317_ed1b5ec7-2812-4a81-90d1-953baa0b0ec8.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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	681b6b25-4a28-44f2-8042-d5e01a502116	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	dbb1489d-b690-4e53-905d-7fb07ad263b3	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	St. Mary's Medical Park Pharmacy	5f4b69de-8ddd-26c5-e053-2a91aa0ab326	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	1eb7a7bb-c524-4168-8ade-4601dc11533b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	ed1b5ec7-2812-4a81-90d1-953baa0b0ec8	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863 ndc (product): 68788-8193
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	e9ec5462-939a-4022-8946-5d81869a6277	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	47ce6fab-be1d-0076-e063-6294a90add63	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	BluePoint Laboratories	feb1541a-de83-47dd-be03-c43376527318	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Rising Pharma Holdings, Inc.	3330ea92-fc9d-4541-b378-be399b0995d3	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	Coupler LLC	2ce0741a-7bc7-8aec-e063-6294a90ae9ef	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	62edf474-9c16-d535-e053-2991aa0a4a09	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac DR	DICLOFENAC	Advanced Rx of Tennessee, LLC	af8a30fb-ead8-7e29-e053-2a95a90a040f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	50efc183-dd3e-4eb7-ba5c-c42fd76e0b65	2023-12-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077863 application number: ANDA077863

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	ed1b5ec7-2812-4a81-90d1-953baa0b0ec8	5
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	ed1b5ec7-2812-4a81-90d1-953baa0b0ec8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8193-1	68788819301	100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-1)	2022-05-16	0000-00-00	No	No	Current
68788-8193-3	68788819303	30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-3)	2022-05-16	0000-00-00	No	No	Current
68788-8193-6	68788819306	60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-6)	2022-05-16	0000-00-00	No	No	Current
68788-8193-8	68788819308	120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-8)	2022-05-16	0000-00-00	No	No	Current
68788-8193-9	68788819309	90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-9)	2022-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg	Preferred Pharmaceuticals Inc.	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	5