DIFLUNISAL

Product NDC: 52959-379
11-digit product format: 529590379
Labeler code: 52959
Product ID: 52959-379_60e0ecab-9d00-3b1b-e053-2a91aa0af663
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIFLUNISAL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H. J. Harkins Company Inc.
Application: ANDA073673
Marketing category: ANDA
Marketing start: 2017-12-22
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: 2019-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-379		I	Inactivated by FDA	2026-08-03
excluded package	package	52959-379	52959-379-14	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-379	52959-379-15	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-379	52959-379-20	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-379	52959-379-21	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-379	52959-379-30	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-379	52959-379-60	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-379	52959-379-90	I	Inactivated by FDA	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 3 · 168 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	52959-379-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-379-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-379-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-379-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-379-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-379-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-379-90	`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	52959-379-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-379-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-379-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-379-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-379-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-379-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-379-90	`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	52959-379-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-379-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-379-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-379-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-379-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-379-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-379-90	`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	52959-379-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-379-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-379-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-379-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-379-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-379-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-379-90	`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	52959-379-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-379-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-379-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-379-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-379-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-379-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-379-90	`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	52959-379-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-379-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-379-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-379-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-379-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-379-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-379-90	`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	52959-379-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-379-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-379-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-379-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-379-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-379-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-379-90	`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	52959-379-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-379-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-379-15	`ed331223b511…`	`672a5bd82f5f…`

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
A073673-001	DIFLUNISAL	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073673-001	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 · 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	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073673-001	DIFLUNISAL	500MG	TABLET / ORAL	AB	RS	1992-07-31	`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	A073673-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073673-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073673-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073673-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073673-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073673-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073673-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073673-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073673-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073673-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073673-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073673-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073673-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073673-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073673-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073673-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073673-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073673-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073673-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073673-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073673-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073673-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073673-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073673-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073673-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073673-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073673-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073673-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073673-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073673-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073673-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073673-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073673-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073673-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073673-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073673-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073673-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073673-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073673-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073673-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
2323d3f0-80b8-7ff4-d997-b3ca46ce553a	Product name	2	20170802

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-379-14	60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-15	60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-20	60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-21	60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-30	60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-60	60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-90	60e0ecab-9cff-3b1b-e053-2a91aa0af663

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-379-14	DIFLUNISAL	14 in 1 CONTAINER	TABLET, FILM COATED	14	1
52959-379-15	DIFLUNISAL	15 in 1 CONTAINER	TABLET, FILM COATED	15	1
52959-379-20	DIFLUNISAL	20 in 1 CONTAINER	TABLET, FILM COATED	20	1
52959-379-21	DIFLUNISAL	21 in 1 CONTAINER	TABLET, FILM COATED	21	1
52959-379-30	DIFLUNISAL	30 in 1 CONTAINER	TABLET, FILM COATED	30	1
52959-379-60	DIFLUNISAL	60 in 1 CONTAINER	TABLET, FILM COATED	60	1
52959-379-90	DIFLUNISAL	90 in 1 CONTAINER	TABLET, FILM COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-379-15	EA - Each	52959-379	0aa2aa86-b8b5-4957-abe0-c9c95bfedec4	1	2018-01-12
52959-379-20	EA - Each	52959-379	ddd4dc1d-10e6-4412-b6ef-e5d6357c9057	1	2018-01-12
52959-379-30	EA - Each	52959-379	6fedd03c-8259-4d37-8274-12033a21fb3c	1	2018-01-12
52959-379-60	EA - Each	52959-379	d73e2382-f339-44a2-88f6-8ed95548b5b2	1	2018-01-12
52959-379-90	EA - Each	52959-379	0d079ff4-63dc-46e5-96b0-bf9747250a67	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-379	DIFLUNISAL TABLET, FILM COATED [H. J. HARKINS COMPANY INC.]	1	Legacy NDC, 7 package rows	20171222_60e0ecab-9cff-3b1b-e053-2a91aa0af663.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diflunisal	DIFLUNISAL	Teva Pharmaceuticals USA, Inc.	7a78bb38-14d8-4a90-b883-482d4cebf716	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073673 application number: ANDA073673

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197603	diflunisal 500 MG Oral Tablet	PSN	60e0ecab-9cff-3b1b-e053-2a91aa0af663	1
197603	diflunisal 500 MG Oral Tablet	SCD	60e0ecab-9cff-3b1b-e053-2a91aa0af663	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-379-14	52959037914	14 in 1 CONTAINER	Historical
52959-379-15	52959037915	15 in 1 CONTAINER	Historical
52959-379-20	52959037920	20 in 1 CONTAINER	Historical
52959-379-21	52959037921	21 in 1 CONTAINER	Historical
52959-379-30	52959037930	30 in 1 CONTAINER	Historical
52959-379-60	52959037960	60 in 1 CONTAINER	Historical
52959-379-90	52959037990	90 in 1 CONTAINER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIFLUNISAL - H. J. Harkins Company Inc.	H. J. Harkins Company Inc.	2017-12-21	HUMAN PRESCRIPTION DRUG LABEL	1