Diclofenac Sodium and Misoprostol

Product NDC: 10544-949
11-digit product format: 105440949
Labeler code: 10544
Product ID: 10544-949_219cc0f7-1a9c-689c-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium and Misoprostol
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA201089
Marketing category: ANDA
Marketing start: 2015-10-07
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	10544-949		I	Inactivated by FDA		2026-08-17
excluded package	package	10544-949	10544-949-14	I	Inactivated by FDA		2026-08-17

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-949-14	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-949-14	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-949-14	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-949-14	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-949-14	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-949-14	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-949-14	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-949-14	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-949-14	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-949-14	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-949-14	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-949-14	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-949-14	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-949-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-949-14	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-949-14	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-949-14	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-949-14	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-949-14	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-949-14	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10544-949-14	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10544-949-14	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2012-07-09
A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2012-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201089-001	AB
A201089-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201089-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201089-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2012-07-09	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201089-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201089-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201089-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201089-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201089-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201089-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201089-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201089-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201089-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201089-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201089-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201089-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201089-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201089-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201089-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201089-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201089-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201089-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201089-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201089-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201089-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201089-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201089-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201089-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201089-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201089-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201089-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201089-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201089-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201089-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201089-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201089-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201089-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201089-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201089-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201089-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201089-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201089-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201089-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201089-002	AB	1	`bb7c543d1eb4…`

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
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
10544-949-14	2020-01-31	C162847	48780-1	9d75b9d0-7a5f-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
10544-949-14	Diclofenac Sodium and Misoprostol	14 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	14		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-949-14	EA - Each	10544-949	c38a0ea8-163e-49c8-b874-98b944216935	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
MISOPROSTOL	ACTIVE INGREDIENT	0E43V0BB57	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
MISOPROSTOL	ACTIVE MOIETY	0E43V0BB57	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE (15 MPA.S AT 5%)	INACTIVE INGREDIENT	68401960MK	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-949	DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 1 package rows	20151008_219caa9b-96f2-643e-e054-00144ff88e88.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	AvKARE	3643ab1b-9f8f-b2f4-e02d-950d0a02e587	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201089 application number: ANDA201089
Diclofenac Sodium and Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	BluePoint Laboratories	9a22cb4b-e49a-4bd7-b235-47405c302658	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201089 application number: ANDA201089
Diclofenac Sodium and Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Actavis Pharma, Inc.	df8b8660-0c24-4848-8bea-c1b935090c66	2025-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201089 application number: ANDA201089

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	219caa9b-96f2-643e-e054-00144ff88e88	1
1359105	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	219caa9b-96f2-643e-e054-00144ff88e88	1
1359105	diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	219caa9b-96f2-643e-e054-00144ff88e88	1
1359105	diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	219caa9b-96f2-643e-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-949-14	10544094914	14 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium and Misoprostol Delayed-Release Tablets	Blenheim Pharmacal, Inc.	2015-10-08	HUMAN PRESCRIPTION DRUG LABEL	1