PrevidolRx Plus Analgesic Pak

Product NDC: 75840-095
11-digit product format: 758400095
Labeler code: 75840
Product ID: 75840-095_b0e3b0cb-0024-4aa3-a275-fe0982d6f9e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICLOFENAC SODIUM
Dosage form: KIT
Labeler: GenPak Solutions, LLC
Application: ANDA077863
Marketing category: ANDA
Marketing start: 2015-12-15
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	75840-095		I	Inactivated by FDA		2026-08-03
excluded package	package	75840-095	75840-095-01	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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75840-095-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75840-095-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75840-095-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75840-095-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75840-095-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75840-095-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75840-095-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75840-095-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75840-095-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75840-095-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75840-095-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75840-095-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75840-095-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75840-095-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75840-095-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	75840-095-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	75840-095-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	75840-095-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	75840-095-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	75840-095-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	75840-095-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	75840-095-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75840-095-01	2020-01-31	C162847	48780-1	9d75b9d0-412f-f424-e053-dadaa90a57ce	PrevidolRx Plus Analgesic Pak - 095

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75840-095-01	EA - Each	75840-095	373fbb27-13d9-417c-9fa9-73d48e573c5b	1	2016-07-19

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
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PrevidolRx Plus Analgesic Pak - 095	GenPak Solutions, LLC \| Unique Pharmaceutical Laboratories \| Vintage Pharmaceuticals-Huntsville	2016-06-07	HUMAN PRESCRIPTION DRUG LABEL	1