Diclofenac Potassium

Product NDC: 21695-838
11-digit product format: 216950838
Labeler code: 21695
Product ID: 21695-838_d751e65a-5086-4303-864b-bd9ed895a239
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075219
Marketing category: ANDA
Marketing start: 2010-01-21
Marketing end: 0000-00-00
Substance: DICLOFENAC POTASSIUM
Active strength: 50 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: E
Listing certified through: 2017-12-31
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	21695-838		I	Inactivated by FDA	2026-08-11
excluded package	package	21695-838	21695-838-21	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-838	21695-838-30	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-838	21695-838-42	I	Inactivated by FDA	2026-08-11

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 2 · 88 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	21695-838-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-838-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-838-30	`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	21695-838-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-838-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-838-30	`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	21695-838-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-838-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-838-30	`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	21695-838-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-838-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-838-30	`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	21695-838-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-838-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-838-30	`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	21695-838-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-838-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-838-30	`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	21695-838-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-838-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-838-30	`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	21695-838-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-838-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-838-30	`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	21695-838-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-838-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-838-30	`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	21695-838-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-838-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-838-30	`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	21695-838-42	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-838-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-838-30	`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	21695-838-42	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-838-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-838-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-838-42	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-838-21	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-838-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-838-42	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-838-21	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-838-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-838-42	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-838-21	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-838-30	`1332a3947898…`	`d4bfe170f9cd…`

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
A075219-001	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB		1998-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075219-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075219-001	DICLOFENAC POTASSIUM	50MG	TABLET / ORAL	AB	1998-08-06	`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	A075219-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075219-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075219-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075219-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075219-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075219-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075219-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075219-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075219-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075219-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075219-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075219-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075219-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075219-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075219-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075219-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075219-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075219-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075219-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075219-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075219-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075219-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075219-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075219-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075219-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075219-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075219-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075219-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075219-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075219-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075219-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075219-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075219-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075219-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075219-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075219-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075219-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075219-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075219-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075219-001	AB	1	`cb3db0bc1861…`

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
21695-838-21	2019-09-24	C162847	48780-1	934fe258-472e-48b1-e053-8cdaa90a720a	DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only
21695-838-30	2019-09-24	C162847	48780-1	934fe258-472e-48b1-e053-8cdaa90a720a	DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only
21695-838-42	2019-09-24	C162847	48780-1	934fe258-472e-48b1-e053-8cdaa90a720a	DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-838-21	Diclofenac Potassium	21 in 1 BOTTLE	TABLET, FILM COATED	21	1
21695-838-30	Diclofenac Potassium	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
21695-838-42	Diclofenac Potassium	42 in 1 BOTTLE	TABLET, FILM COATED	42	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-838-21	EA - Each	21695-838	cd751e31-d6a4-4247-93e4-41dd8e4b743d	1	2012-07-24
21695-838-30	EA - Each	21695-838	7766a061-c679-4357-b523-b0f65f188530	1	2012-07-24
21695-838-42	EA - Each	21695-838	2d21f2bd-0532-4ad8-ae40-49ec48e92ca3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC POTASSIUM	ACTIVE INGREDIENT	L4D5UA6CB4	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TRICALCIUM PHOSPHATE	INACTIVE INGREDIENT	K4C08XP666	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-838	DICLOFENAC POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 3 package rows	20110407_d751e65a-5086-4303-864b-bd9ed895a239.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Potassium	DICLOFENAC POTASSIUM	Preferred Pharmaceuticals Inc.	8dfaa874-d6cf-4107-b57f-25dab02aa201	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219
Diclofenac Potassium	DICLOFENAC POTASSIUM	PD-Rx Pharmaceuticals, Inc.	08e41a9d-644c-4ac6-aba3-38d7c3f36d36	2025-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219
Diclofenac Potassium	DICLOFENAC POTASSIUM	Teva Pharmaceuticals USA, Inc.	77b60a0c-e49a-4ad4-abb1-b662c24ab782	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219
Diclofenac Potassium	DICLOFENAC POTASSIUM	NuCare Pharmaceuticals, Inc.	3da9e463-1b2f-54c0-e054-00144ff88e88	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219
Diclofenac Potassium	DICLOFENAC POTASSIUM	Bryant Ranch Prepack	717341fc-e067-0005-215c-053f6d12e0d1	2023-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075219 application number: ANDA075219

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L4D5UA6CB4	DICLOFENAC POTASSIUM	15307-81-0	DICLOFENAC POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855942	diclofenac potassium 50 MG Oral Tablet	PSN	d751e65a-5086-4303-864b-bd9ed895a239	1
855942	diclofenac potassium 50 MG Oral Tablet	SCD	d751e65a-5086-4303-864b-bd9ed895a239	1
855942	Diclofenac K+ 50 MG Oral Tablet	SY	d751e65a-5086-4303-864b-bd9ed895a239	1
855942	Diclofenac Pot 50 MG Oral Tablet	SY	d751e65a-5086-4303-864b-bd9ed895a239	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-838-21	21695083821	21 in 1 BOTTLE	Historical
21695-838-30	21695083830	30 in 1 BOTTLE	Historical
21695-838-42	21695083842	42 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only	Rebel Distributors Corp	2010-09-24	HUMAN PRESCRIPTION DRUG LABEL	1