Cytotec

Product NDC: 55289-248
11-digit product format: 552890248
Labeler code: 55289
Product ID: 55289-248_d9300344-088b-3049-e053-2995a90ac65d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: misoprostol
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: NDA019268
Marketing category: NDA
Marketing start: 1986-12-27
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55289-248		D	Discontinued by firm		2026-08-07
excluded package	package	55289-248	55289-248-28	D	Discontinued by firm		2026-08-07

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 · 24 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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`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	55289-248-28	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 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	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…`
2019-12-13 00:20 UTC	2019-12	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL		RLD, RS	1988-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL		RLD	1990-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL		RLD, RS	1988-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL		RLD	1990-09-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	N019268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019268-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019268-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019268-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019268-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019268-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019268-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019268-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019268-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019268-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019268-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019268-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019268-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019268-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019268-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019268-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019268-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019268-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019268-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019268-003	AB	1	`5d02ea3f76ae…`
2019-12-13 00:20 UTC	2019-12	N019268-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019268-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019268-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019268-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019268-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019268-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019268-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019268-003	AB	1	`8869cabd3fbd…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-248-28	EA - Each	55289-248	59ec2f04-3f8d-4042-8e5f-1318626ab1c5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
misoprostol	ACTIVE INGREDIENT	0E43V0BB57	CYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]	4
misoprostol	ACTIVE MOIETY	0E43V0BB57	CYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]	4
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]	4
hydrogenated castor oil	INACTIVE INGREDIENT	ZF94AP8MEY	CYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]	4
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]	4

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	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	Mylan Pharmaceuticals Inc.	c4fe14fb-0a43-4c31-9cd6-29eb0d156705	2026-05-23	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-248-28	55289024828	28 TABLET in 1 BOTTLE, PLASTIC (55289-248-28)	28 tablet	2011-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cytotec ® misoprostol tablets	PD-Rx Pharmaceuticals, Inc.	2022-03-01	HUMAN PRESCRIPTION DRUG LABEL	18