ARTHROTEC

Product NDC: 21695-425
11-digit product format: 216950425
Labeler code: 21695
Product ID: 21695-425_0d527c1c-19c5-4199-a51d-b953798d42a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium and misoprostol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: NDA020607
Marketing category: NDA
Marketing start: 1997-12-24
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM; MISOPROSTOL
Active strength: 75 mg/1; ug/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-425		I	Inactivated by FDA		2026-08-10
excluded package	package	21695-425	21695-425-60	I	Inactivated by FDA		2026-08-10

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	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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`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	21695-425-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-425-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-425-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-425-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-425-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-425-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-425-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-425-60	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020607-001	ARTHROTEC	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24
N020607-002	ARTHROTEC	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020607-001	AB
N020607-002	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 3 · 82 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	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020607-001	ARTHROTEC	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	1997-12-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020607-002	ARTHROTEC	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1997-12-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N020607-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020607-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020607-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020607-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020607-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020607-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020607-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020607-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020607-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020607-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020607-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020607-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020607-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020607-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020607-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020607-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020607-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020607-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020607-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020607-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020607-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020607-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020607-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020607-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020607-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020607-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020607-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020607-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020607-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020607-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020607-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020607-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020607-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020607-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020607-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020607-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020607-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020607-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020607-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020607-002	AB	1	`782e0a99824c…`

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
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9	Product name	3	20231221
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
21695-425-60	2019-09-24	C162847	48780-1	934fe258-4ce6-48b1-e053-8cdaa90a720a	ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-425-60	ARTHROTEC	60 in 1 BOTTLE	TABLET, FILM COATED	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-425-60	EA - Each	21695-425	81684d6d-34a7-47e4-9f87-95955c497e06	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
diclofenac sodium	ACTIVE INGREDIENT	QTG126297Q	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
misoprostol	ACTIVE INGREDIENT	0E43V0BB57	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
diclofenac	ACTIVE MOIETY	144O8QL0L1	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
misoprostol	ACTIVE MOIETY	0E43V0BB57	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
hydrogenated castor oil	INACTIVE INGREDIENT	ZF94AP8MEY	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
povidone K30	INACTIVE INGREDIENT	U725QWY32X	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) 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
21695-425	ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 1 package rows	20091123_1cdede45-4e2b-490a-bd22-eca5315af316.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium and Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Mylan Pharmaceuticals Inc.	a7701e8c-4e16-4165-8b83-de2c08d5ded3	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020607 application number: NDA020607
ARTHROTEC	DICLOFENAC SODIUM AND MISOPROSTOL	Pfizer Laboratories Div Pfizer Inc	600fe842-45d9-4d68-9ef2-456dbbebaa11	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020607 application number: NDA020607
Diclofenac sodium and Misoprostol DR	DICLOFENAC SODIUM AND MISOPROSTOL	Advanced Rx Pharmacy of Tennessee, LLC	1213d3eb-9870-f144-e063-6394a90a6088	2024-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020607 application number: NDA020607

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM
0E43V0BB57	MISOPROSTOL	59122-46-2	MISOPROSTOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1359109	Arthrotec 75 MG / 200 MCG Delayed Release Oral Tablet	PSN	1cdede45-4e2b-490a-bd22-eca5315af316	1
1359105	diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	1cdede45-4e2b-490a-bd22-eca5315af316	1
1359109	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet [Arthrotec]	SBD	1cdede45-4e2b-490a-bd22-eca5315af316	1
1359105	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	1cdede45-4e2b-490a-bd22-eca5315af316	1
1359109	Arthrotec (diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG) Delayed Release Oral Tablet	SY	1cdede45-4e2b-490a-bd22-eca5315af316	1
1359105	diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	1cdede45-4e2b-490a-bd22-eca5315af316	1
1359105	diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	1cdede45-4e2b-490a-bd22-eca5315af316	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-425-60	21695042560	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets	Rebel Distributors Corp.	2009-11-10	HUMAN PRESCRIPTION DRUG LABEL	1