misoprostol

Product NDC: 52959-692
11-digit product format: 529590692
Labeler code: 52959
Product ID: 52959-692_9355aee3-c2a5-485f-ae95-cf93bfc0a57f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: misoprostol
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: NDA019268
Marketing category: NDA
Marketing start: 2009-12-27
Marketing end: 0000-00-00
Substance: MISOPROSTOL
Active strength: 100 ug/1
Pharmacologic classes: 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-692		I	Inactivated by FDA	2026-10-16
excluded package	package	52959-692	52959-692-12	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-692	52959-692-28	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-692	52959-692-30	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-692	52959-692-40	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-692	52959-692-60	I	Inactivated by FDA	2026-10-16

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 3 · 132 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	52959-692-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-692-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-692-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-692-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-692-28	`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	52959-692-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-692-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-692-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-692-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-692-28	`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	52959-692-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-692-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-692-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-692-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-692-28	`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	52959-692-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-692-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-692-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-692-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-692-28	`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	52959-692-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-692-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-692-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-692-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-692-28	`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	52959-692-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-692-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-692-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-692-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-692-28	`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	52959-692-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-692-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-692-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-692-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-692-28	`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	52959-692-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-692-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-692-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-692-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-692-28	`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	52959-692-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-692-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-692-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-692-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-692-28	`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	52959-692-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-692-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-692-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-692-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-692-28	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019268-001	CYTOTEC	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27
N019268-003	CYTOTEC	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019268-001	AB
N019268-003	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 · 88 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
2026-10-15 13:18:30	2026-09	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL		RLD, RS	1988-12-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL		RLD	1990-09-21	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019268-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019268-003	AB	1	`a50c72e98297…`

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
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9	Product name	3	20231221
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-692-12	Misoprostol Tablets
52959-692-28	Misoprostol Tablets
52959-692-30	Misoprostol Tablets
52959-692-40	Misoprostol Tablets
52959-692-60	Misoprostol Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-692-12	misoprostol	12 in 1 BOTTLE	TABLET	12	2
52959-692-28	misoprostol	28 in 1 BOTTLE	TABLET	28	2
52959-692-30	misoprostol	30 in 1 BOTTLE	TABLET	30	2
52959-692-40	misoprostol	40 in 1 BOTTLE	TABLET	40	2
52959-692-60	misoprostol	60 in 1 BOTTLE	TABLET	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-692-12	EA - Each	52959-692	d91a9ca1-d507-4e87-b413-aebed276dfc4	1	2012-07-24
52959-692-28	EA - Each	52959-692	5c5731cb-de73-4b3c-a388-0375cc326354	1	2012-07-24
52959-692-30	EA - Each	52959-692	c1cf1682-c8e9-440f-b677-420bf15d5be3	1	2012-07-24
52959-692-40	EA - Each	52959-692	2c877558-8bd7-4392-9ffd-0d98c0e78e9b	1	2012-07-24
52959-692-60	EA - Each	52959-692	46821f8d-3630-49ee-9c49-d8562c6afb90	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
misoprostol	ACTIVE INGREDIENT	0E43V0BB57	MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]	2
misoprostol	ACTIVE MOIETY	0E43V0BB57	MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]	2
hydrogenated castor oil	INACTIVE INGREDIENT	ZF94AP8MEY	MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-692	MISOPROSTOL TABLET [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 5 package rows	20120120_a5e5413d-bc22-4ae1-959b-0eb0430dbd38.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
misoprostol	MISOPROSTOL	Mylan Pharmaceuticals Inc.	c4fe14fb-0a43-4c31-9cd6-29eb0d156705	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019268 application number: NDA019268
misoprostol	MISOPROSTOL	Bryant Ranch Prepack	c842c35f-6a64-4ecc-95a1-41b6d056047e	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019268 application number: NDA019268
Cytotec	MISOPROSTOL	Pfizer Laboratories Div Pfizer Inc	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019268 application number: NDA019268
misoprostol	MISOPROSTOL	Redpharm Drug	2fd197c6-05db-5011-e063-6294a90a585d	2025-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019268 application number: NDA019268

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0E43V0BB57	MISOPROSTOL	59122-46-2	MISOPROSTOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311727	miSOPROStol 100 MCG Oral Tablet	PSN	a5e5413d-bc22-4ae1-959b-0eb0430dbd38	2
311727	misoprostol 0.1 MG Oral Tablet	SCD	a5e5413d-bc22-4ae1-959b-0eb0430dbd38	2
311727	misoprostol 100 MCG Oral Tablet	SY	a5e5413d-bc22-4ae1-959b-0eb0430dbd38	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-692-12	52959069212	12 in 1 BOTTLE	Historical
52959-692-28	52959069228	28 in 1 BOTTLE	Historical
52959-692-30	52959069230	30 in 1 BOTTLE	Historical
52959-692-40	52959069240	40 in 1 BOTTLE	Historical
52959-692-60	52959069260	60 in 1 BOTTLE	Historical