Diclofenac sodium and Misoprostol

Product NDC: 80425-0272
11-digit product format: 804250272
Labeler code: 80425
Product ID: 80425-0272_1213898d-dffc-ce28-e063-6394a90a1a28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac sodium and Misoprostol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: NDA020607
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-02-23
Substance: DICLOFENAC SODIUM; MISOPROSTOL
Active strength: 75; 200 mg/1; ug/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac sodium and Misoprostol
Brand name suffix: DR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	75 mg/1
MISOPROSTOL	200 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup
0E43V0BB57	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1359105	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1213d3eb-9870-f144-e063-6394a90a6088	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0272-1	Diclofenac sodium and MisoprostolDR	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
80425-0272-1	EA - Each	80425-0272	43394095-1b48-4f83-bce6-1e33acf2768f	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0272	DICLOFENAC SODIUM AND MISOPROSTOL DR (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	1	Current NDC, 1 package rows	20240224_1213d3eb-9870-f144-e063-6394a90a6088.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 ndc (product): 80425-0272

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
1359105	diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	1213d3eb-9870-f144-e063-6394a90a6088	1
1359105	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	1213d3eb-9870-f144-e063-6394a90a6088	1
1359105	diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	1213d3eb-9870-f144-e063-6394a90a6088	1
1359105	diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	1213d3eb-9870-f144-e063-6394a90a6088	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0272-1	80425027201	60 TABLET, FILM COATED in 1 BOTTLE (80425-0272-1)	2024-02-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac sodium and Misoprostol DR	Advanced Rx Pharmacy of Tennessee, LLC	2024-02-23	HUMAN PRESCRIPTION DRUG LABEL	1