Cytotec

Product NDC: 0025-1461
Requested package NDC: 0025-1461-60
11-digit product format: 000251461
Labeler code: 0025
Product ID: 0025-1461_253d5240-18d7-4f06-8314-a5632648cd47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: misoprostol
Dosage form: TABLET
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA019268
Marketing category: NDA
Marketing start: 1986-12-27
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

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0025-1461	0025-1461-60	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cytotec
Listing expiration: 2027-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104098	Internal RxNorm lookup
209177	Internal RxNorm lookup
311727	Internal RxNorm lookup
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
4ab12da7-5731-4e06-bf1c-bc3f2e711f12	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	SPL version
0025-1461-31	Cytotec	100 in 1 BOTTLE, UNIT-DOSE	TABLET	100	21
0025-1461-34	Cytotec	100 in 1 CARTON	TABLET	100	21
0025-1461-34	Cytotec	1 in 1 BLISTER PACK	TABLET	1	21
0025-1461-60	Cytotec	60 in 1 BOTTLE, UNIT-DOSE	TABLET	60	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0025-1461-31	EA - Each	0025-1461	86bf4365-ecf7-4493-90ba-cbead63d0a46	1	2012-07-24
0025-1461-34	EA - Each	0025-1461	3b22c2e0-862d-4389-9103-27bf170f85c6	1	2012-07-24
0025-1461-60	EA - Each	0025-1461	c9fb7536-5c95-4eda-ab4b-cbc02aae7e32	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 [G.D. SEARLE LLC DIVISION OF PFIZER INC]	7
MISOPROSTOL	ACTIVE MOIETY	0E43V0BB57	CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	7
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	7
MISOPROSTOL	ACTIVE INGREDIENT	0E43V0BB57	CYTOTEC (MISOPROSTOL) TABLET [APOTHECA, INC]	1
MISOPROSTOL	ACTIVE MOIETY	0E43V0BB57	CYTOTEC (MISOPROSTOL) TABLET [APOTHECA, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0025-1461	CYTOTEC (MISOPROSTOL) TABLET [PFIZER LABORATORIES DIV PFIZER INC]	19	Current NDC, Legacy NDC, 4 package rows	20250221_4ab12da7-5731-4e06-bf1c-bc3f2e711f12.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	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 ndc (package): 0025-1461-60 ndc (product): 0025-1461 ndc11 (package): 00025146160
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
209177	Cytotec 100 MCG Oral Tablet	PSN	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
104098	Cytotec 200 MCG Oral Tablet	PSN	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
311727	miSOPROStol 100 MCG Oral Tablet	PSN	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
317128	miSOPROStol 200 MCG Oral Tablet	PSN	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
209177	misoprostol 0.1 MG Oral Tablet [Cytotec]	SBD	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
104098	misoprostol 0.2 MG Oral Tablet [Cytotec]	SBD	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
311727	misoprostol 0.1 MG Oral Tablet	SCD	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
317128	misoprostol 0.2 MG Oral Tablet	SCD	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
104098	Cyotec 200 MCG Oral Tablet	SY	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
209177	Cytotec 0.1 MG Oral Tablet	SY	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
104098	Cytotec 0.2 MG Oral Tablet	SY	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
209177	Cytotec 100 MCG Oral Tablet	SY	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
311727	misoprostol 100 MCG Oral Tablet	SY	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
317128	misoprostol 200 MCG Oral Tablet	SY	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	21
104098	Cytotec 200 MCG Oral Tablet	PSN	10644068-fa47-4e3b-9e93-f57ebac3dd17	1
317128	miSOPROStol 200 MCG Oral Tablet	PSN	10644068-fa47-4e3b-9e93-f57ebac3dd17	1
104098	misoprostol 0.2 MG Oral Tablet [Cytotec]	SBD	10644068-fa47-4e3b-9e93-f57ebac3dd17	1
317128	misoprostol 0.2 MG Oral Tablet	SCD	10644068-fa47-4e3b-9e93-f57ebac3dd17	1
104098	Cyotec 200 MCG Oral Tablet	SY	10644068-fa47-4e3b-9e93-f57ebac3dd17	1
104098	Cytotec 0.2 MG Oral Tablet	SY	10644068-fa47-4e3b-9e93-f57ebac3dd17	1
317128	misoprostol 200 MCG Oral Tablet	SY	10644068-fa47-4e3b-9e93-f57ebac3dd17	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0025-1461-60	00025146160	60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-60)	60 tablet	1986-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cytotec ® misoprostol tablets	Pfizer Laboratories Div Pfizer Inc	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	22
Cytotec® 200 MCG Tablets USP Tradename of Pfizer (misoprostol)	Apotheca, Inc	2010-04-01	HUMAN PRESCRIPTION DRUG LABEL	1