DIFLUNISAL

Product NDC: 64980-181
11-digit product format: 649800181
Labeler code: 64980
Product ID: 64980-181_5a68ac1c-94bd-4583-8c87-38618bd3f2a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIFLUNISAL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharmaceuticals Inc.
Application: ANDA202845
Marketing category: ANDA
Marketing start: 2012-05-01
Marketing end: 0000-00-00
Substance: DIFLUNISAL
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64980-181		D	Discontinued by firm	2026-08-03
excluded package	package	64980-181	64980-181-01	D	Discontinued by firm	2026-08-03
excluded package	package	64980-181	64980-181-05	D	Discontinued by firm	2026-08-03
excluded package	package	64980-181	64980-181-06	D	Discontinued by firm	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 · 48 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	64980-181-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-181-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-181-06	`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	64980-181-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-181-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-181-06	`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	64980-181-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-181-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-181-06	`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	64980-181-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-181-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-181-06	`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	64980-181-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-181-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-181-06	`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	64980-181-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-181-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-181-06	`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	64980-181-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-181-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-181-06	`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	64980-181-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64980-181-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64980-181-06	`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	64980-181-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64980-181-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64980-181-06	`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	64980-181-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64980-181-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64980-181-06	`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	64980-181-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64980-181-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64980-181-06	`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	64980-181-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64980-181-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64980-181-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202845-001	DIFLUNISAL	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08
A202845-002	DIFLUNISAL	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16
A202845-003	DIFLUNISAL	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202845-001	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 · 63 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	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202845-002	DIFLUNISAL	250MG	TABLET / ORAL		2024-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202845-003	DIFLUNISAL	375MG	TABLET / ORAL		2024-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202845-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	2012-03-08	`782e0a99824c…`

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	A202845-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202845-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202845-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202845-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202845-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202845-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202845-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202845-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202845-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202845-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202845-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202845-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202845-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202845-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202845-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202845-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202845-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202845-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202845-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202845-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202845-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202845-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202845-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202845-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202845-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202845-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202845-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202845-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202845-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202845-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202845-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202845-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202845-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202845-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202845-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202845-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202845-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202845-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202845-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202845-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-181-01	EA - Each	64980-181	a6f1a4dc-2fcd-48cc-b63b-b44790e2845a	1	2013-02-13
64980-181-05	EA - Each	64980-181	52c15411-b75f-4d66-aa3b-248a0521fafa	1	2013-02-13
64980-181-06	EA - Each	64980-181	bbff773a-fe0f-492c-bf8a-38a2f2461f51	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIFLUNISAL	ACTIVE INGREDIENT	7C546U4DEN	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
DIFLUNISAL	ACTIVE MOIETY	7C546U4DEN	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIFLUNISAL TABLET, FILM COATED [RISING PHARMACEUTICALS INC.]	4

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolobid	DIFLUNISAL	INA Pharmaceutics Inc	725234b2-0e23-45c3-a42d-eb4e62273f9b	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845
Diflunisal	DIFLUNISAL	Chartwell RX, LLC	2043bab8-87c9-45ce-88c7-383f0d4c4b64	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845
diflunisal	DIFLUNISAL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	666f89b4-fd81-420a-a390-eb1cd4014f61	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202845 application number: ANDA202845

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7C546U4DEN	DIFLUNISAL	22494-42-4	DIFLUNISAL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-181-01	64980018101	100 TABLET, FILM COATED in 1 BOTTLE (64980-181-01)	2012-05-01	0000-00-00	No	No	Current
64980-181-05	64980018105	500 TABLET, FILM COATED in 1 BOTTLE (64980-181-05)	2012-05-01	0000-00-00	No	No	Current
64980-181-06	64980018106	60 TABLET, FILM COATED in 1 BOTTLE (64980-181-06)	2012-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diflunisal Tablets USP, 500 mg Rx only	Rising Pharmaceuticals Inc. \| Heritage Pharma Labs, Inc	2016-05-10	HUMAN PRESCRIPTION DRUG LABEL	6