misoprostol

Product NDC: 67296-1936
Requested package NDC: 67296-1936-1
11-digit product format: 672961936
Labeler code: 67296
Product ID: 67296-1936_46e93923-334c-68db-e063-6394a90ad902
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MISOPROSTOL
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: NDA019268
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-12-27
Substance: MISOPROSTOL
Active strength: 200 ug/1
Pharmacologic classes: Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
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 · 86 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
2026-09-14 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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019268-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019268-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019268-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019268-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: misoprostol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MISOPROSTOL	200 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0E43V0BB57	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317128	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2fd197c6-05db-5011-e063-6294a90a585d	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1936-1	misoprostol	10 in 1 BOTTLE	TABLET	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1936	MISOPROSTOL TABLET [REDPHARM DRUG]	1	Current NDC, 1 package rows	20250309_2fd197c6-05db-5011-e063-6294a90a585d.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 ndc (package): 67296-1936-1 ndc (product): 67296-1936 ndc11 (package): 67296193601

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
317128	miSOPROStol 200 MCG Oral Tablet	PSN	2fd197c6-05db-5011-e063-6294a90a585d	3
317128	misoprostol 0.2 MG Oral Tablet	SCD	2fd197c6-05db-5011-e063-6294a90a585d	3
317128	misoprostol 200 MCG Oral Tablet	SY	2fd197c6-05db-5011-e063-6294a90a585d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-1936-1	67296193601	10 TABLET in 1 BOTTLE (67296-1936-1)	10 tablet	2009-12-27	No	No	Current