ARTHROTEC

Product NDC: 49999-987
11-digit product format: 499990987
Labeler code: 49999
Product ID: 49999-987_58ee63d2-8ee3-491f-b7c6-e473160d13cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium and misoprostol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Application: NDA020607
Marketing category: NDA
Marketing start: 2012-02-23
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49999-987		D	Discontinued by firm		2026-08-07
excluded package	package	49999-987	49999-987-60	D	Discontinued by firm		2026-08-07

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 · 24 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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`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	49999-987-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-987-60	EA - Each	49999-987	ba1c5a75-3675-435a-845e-6b2a9981547d	1	2012-07-24

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