Diclofenac Sodium and Misoprostol

Product NDC: 42367-110
11-digit product format: 423670110
Labeler code: 42367
Product ID: 42367-110_a9cea5dd-d282-4ba2-ac44-d8b01eceffb1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium and Misoprostol
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Eagle Pharmaceuticals, Inc.
Application: ANDA200540
Marketing category: ANDA
Marketing start: 2014-07-15
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM; MISOPROSTOL
Active strength: 50 mg/1; mg/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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42367-110		I	Inactivated by FDA	2026-10-05
excluded package	package	42367-110	42367-110-06	I	Inactivated by FDA	2026-10-05
excluded package	package	42367-110	42367-110-09	I	Inactivated by FDA	2026-10-05

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 · 63 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	42367-110-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42367-110-06	`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	42367-110-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42367-110-06	`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	42367-110-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42367-110-06	`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	42367-110-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42367-110-06	`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	42367-110-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42367-110-06	`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	42367-110-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42367-110-06	`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	42367-110-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42367-110-06	`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	42367-110-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42367-110-06	`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	42367-110-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42367-110-06	`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	42367-110-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42367-110-06	`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	42367-110-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42367-110-06	`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	42367-110-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42367-110-06	`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	42367-110-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42367-110-06	`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	42367-110-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42367-110-06	`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	42367-110-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42367-110-06	`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	42367-110-09	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42367-110-06	`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	42367-110-09	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42367-110-06	`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	42367-110-09	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42367-110-06	`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	42367-110-09	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42367-110-06	`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	42367-110-09	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42367-110-06	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL			2014-03-14
A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL			2014-03-14

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200540-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200540-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	2014-03-14	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A200540-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200540-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200540-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200540-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
42367-110-06	2020-01-31	C162847	48780-1	9d75b9d0-9fd0-f424-e053-dadaa90a57ce	Diclofenac sodium and misoprostol delayed-release tablets
42367-110-09	2020-01-31	C162847	48780-1	9d75b9d0-9fd0-f424-e053-dadaa90a57ce	Diclofenac sodium and misoprostol delayed-release tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42367-110-06	Diclofenac Sodium and Misoprostol Delayed-Release	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60		3
42367-110-09	Diclofenac Sodium and Misoprostol Delayed-Release	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42367-110-06	EA - Each	42367-110	1d6d5463-5ac8-439d-a769-79ae7ca20b14	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diclofenac sodium	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
Misoprostol	ACTIVE INGREDIENT	0E43V0BB57	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
Diclofenac	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
Misoprostol	ACTIVE MOIETY	0E43V0BB57	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
hydrogenated castor oil	INACTIVE INGREDIENT	ZF94AP8MEY	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
methacrylic acid - ethyl acrylate copolymer (1:1) type a	INACTIVE INGREDIENT	NX76LV5T8J	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
povidone k30	INACTIVE INGREDIENT	U725QWY32X	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42367-110	DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.]	3	Legacy NDC, 2 package rows	20140715_4616cae3-c91b-477c-94b0-d3f4468a59d9.zip

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
857706	diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	4616cae3-c91b-477c-94b0-d3f4468a59d9	3
1359105	diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	4616cae3-c91b-477c-94b0-d3f4468a59d9	3
857706	diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	4616cae3-c91b-477c-94b0-d3f4468a59d9	3
1359105	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	4616cae3-c91b-477c-94b0-d3f4468a59d9	3
857706	diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	4616cae3-c91b-477c-94b0-d3f4468a59d9	3
1359105	diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	4616cae3-c91b-477c-94b0-d3f4468a59d9	3
857706	diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	4616cae3-c91b-477c-94b0-d3f4468a59d9	3
1359105	diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	4616cae3-c91b-477c-94b0-d3f4468a59d9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42367-110-06	42367011006	60 in 1 BOTTLE	Historical
42367-110-09	42367011009	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac sodium and misoprostol delayed-release tablets	Eagle Pharmaceuticals, Inc. \| Cipla Limited	2014-07-18	HUMAN PRESCRIPTION DRUG LABEL	3