Diclofenac Sodium/Misoprostol

Product NDC: 68788-8214
11-digit product format: 687888214
Labeler code: 68788
Product ID: 68788-8214_869878e8-7391-4206-8b83-3e06fc5a4d2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium/Misoprostol
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA204355
Marketing category: ANDA
Marketing start: 2022-09-08
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM; MISOPROSTOL
Active strength: 75 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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-8214		D	Discontinued by firm	2026-08-07
excluded package	package	68788-8214	68788-8214-3	D	Discontinued by firm	2026-08-07
excluded package	package	68788-8214	68788-8214-6	D	Discontinued by firm	2026-08-07

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
A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-07-15
A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204355-001	AB
A204355-002	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 2 · 66 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	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A204355-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204355-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204355-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204355-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204355-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204355-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204355-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204355-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204355-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204355-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204355-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204355-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204355-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204355-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204355-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204355-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-002	AB	1	`6a51e52b5d6a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8214-3	EA - Each	68788-8214	4f3890e7-f959-4647-b382-fd64775e0f67	1	2022-09-12
68788-8214-6	EA - Each	68788-8214	9e386f65-281e-49b2-875c-cecc28f860da	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8214	DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL (DICLOFENAC SODIUM/MISOPROSTOL) TABLET [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20250316_869878e8-7391-4206-8b83-3e06fc5a4d2a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Sportpharm LLC	0d6509a1-7af8-473b-8951-c19439274379	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Micro Labs Limited	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Bryant Ranch Prepack	7225385c-501c-4e90-8948-8617d583108c	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355
DICLOENAC SODIUM and MISOPROSTOL DR	DICLOENAC SODIUM AND MISOPROSTOL	Advanced Rx Pharmacy of Tennessee, LLC	f4d8c198-63e1-3109-e053-2995a90acad9	2024-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8214-3	68788821403	30 TABLET in 1 BOTTLE (68788-8214-3)	30 tablet	2022-09-08	0000-00-00	No	No	Current
68788-8214-6	68788821406	60 TABLET in 1 BOTTLE (68788-8214-6)	60 tablet	2022-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol	Preferred Pharmaceuticals Inc.	2025-03-14	HUMAN PRESCRIPTION DRUG LABEL	4