misoprostol

Product NDC: 12634-502
Requested package NDC: 12634-502-45
11-digit product format: 126340502
Labeler code: 12634
Product ID: 12634-502_477e9a4a-19a9-6846-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MISOPROSTOL
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: NDA019268
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-12-27
Marketing end: 0000-00-00
Substance: MISOPROSTOL
Active strength: 200 ug/1
Pharmacologic classes: Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	12634-502	12634-502-45	I	Inactivated by FDA		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 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`

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 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
12634-502-00	Misoprostol Tablets
12634-502-01	Misoprostol Tablets
12634-502-09	Misoprostol Tablets
12634-502-12	Misoprostol Tablets
12634-502-18	Misoprostol Tablets
12634-502-40	Misoprostol Tablets
12634-502-42	Misoprostol Tablets
12634-502-45	Misoprostol Tablets
12634-502-50	Misoprostol Tablets
12634-502-52	Misoprostol Tablets
12634-502-54	Misoprostol Tablets
12634-502-57	Misoprostol Tablets
12634-502-59	Misoprostol Tablets
12634-502-60	Misoprostol Tablets
12634-502-61	Misoprostol Tablets
12634-502-63	Misoprostol Tablets
12634-502-66	Misoprostol Tablets
12634-502-67	Misoprostol Tablets
12634-502-69	Misoprostol Tablets
12634-502-71	Misoprostol Tablets
12634-502-74	Misoprostol Tablets
12634-502-78	Misoprostol Tablets
12634-502-79	Misoprostol Tablets
12634-502-80	Misoprostol Tablets
12634-502-81	Misoprostol Tablets
12634-502-82	Misoprostol Tablets
12634-502-84	Misoprostol Tablets
12634-502-85	Misoprostol Tablets
12634-502-90	Misoprostol Tablets
12634-502-91	Misoprostol Tablets
12634-502-92	Misoprostol Tablets
12634-502-93	Misoprostol Tablets
12634-502-94	Misoprostol Tablets
12634-502-95	Misoprostol Tablets
12634-502-96	Misoprostol Tablets
12634-502-97	Misoprostol Tablets
12634-502-98	Misoprostol Tablets
12634-502-99	Misoprostol Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-502-00	misoprostol	10 in 1 BOTTLE	TABLET	10	6
12634-502-01	misoprostol	100 in 1 BOTTLE	TABLET	100	6
12634-502-09	misoprostol	35 in 1 BOTTLE	TABLET	35	6
12634-502-12	misoprostol	120 in 1 BOTTLE	TABLET	120	6
12634-502-18	misoprostol	180 in 1 BOTTLE	TABLET	180	6
12634-502-40	misoprostol	40 in 1 BOTTLE	TABLET	40	6
12634-502-42	misoprostol	42 in 1 BOTTLE	TABLET	42	6
12634-502-45	misoprostol	45 in 1 BOTTLE	TABLET	45	6
12634-502-50	misoprostol	50 in 1 BOTTLE	TABLET	50	6
12634-502-52	misoprostol	12 in 1 BLISTER PACK	TABLET	12	6
12634-502-54	misoprostol	14 in 1 BLISTER PACK	TABLET	14	6
12634-502-57	misoprostol	20 in 1 BLISTER PACK	TABLET	20	6
12634-502-59	misoprostol	30 in 1 BLISTER PACK	TABLET	30	6
12634-502-60	misoprostol	60 in 1 BOTTLE	TABLET	60	6
12634-502-61	misoprostol	10 in 1 BLISTER PACK	TABLET	10	6
12634-502-63	misoprostol	3 in 1 BLISTER PACK	TABLET	3	6
12634-502-66	misoprostol	6 in 1 BLISTER PACK	TABLET	6	6
12634-502-67	misoprostol	7 in 1 BLISTER PACK	TABLET	7	6
12634-502-69	misoprostol	9 in 1 BLISTER PACK	TABLET	9	6
12634-502-71	misoprostol	30 in 1 BOTTLE	TABLET	30	6
12634-502-74	misoprostol	24 in 1 BOTTLE	TABLET	24	6
12634-502-78	misoprostol	28 in 1 BOTTLE	TABLET	28	6
12634-502-79	misoprostol	25 in 1 BOTTLE	TABLET	25	6
12634-502-80	misoprostol	20 in 1 BOTTLE	TABLET	20	6
12634-502-81	misoprostol	21 in 1 BOTTLE	TABLET	21	6
12634-502-82	misoprostol	12 in 1 BOTTLE	TABLET	12	6
12634-502-84	misoprostol	14 in 1 BOTTLE	TABLET	14	6
12634-502-85	misoprostol	15 in 1 BOTTLE	TABLET	15	6
12634-502-90	misoprostol	90 in 1 BOTTLE	TABLET	90	6
12634-502-91	misoprostol	1 in 1 BLISTER PACK	TABLET	1	6
12634-502-92	misoprostol	2 in 1 BOTTLE	TABLET	2	6
12634-502-93	misoprostol	3 in 1 BOTTLE	TABLET	3	6
12634-502-94	misoprostol	4 in 1 BOTTLE	TABLET	4	6
12634-502-95	misoprostol	5 in 1 BOTTLE	TABLET	5	6
12634-502-96	misoprostol	6 in 1 BOTTLE	TABLET	6	6
12634-502-97	misoprostol	7 in 1 BOTTLE	TABLET	7	6
12634-502-98	misoprostol	8 in 1 BOTTLE	TABLET	8	6
12634-502-99	misoprostol	9 in 1 BOTTLE	TABLET	9	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MISOPROSTOL	ACTIVE INGREDIENT	0E43V0BB57	MISOPROSTOL TABLET [APOTHECA, INC.]	2
MISOPROSTOL	ACTIVE MOIETY	0E43V0BB57	MISOPROSTOL TABLET [APOTHECA, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MISOPROSTOL TABLET [APOTHECA, INC.]	2
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	MISOPROSTOL TABLET [APOTHECA, INC.]	2
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	MISOPROSTOL TABLET [APOTHECA, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MISOPROSTOL TABLET [APOTHECA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-502	MISOPROSTOL TABLET [APOTHECA INC.]	6	Legacy NDC, 38 package rows	20170303_f15b41bd-ed36-4908-aba5-f0a019b7a26e.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
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
317128	miSOPROStol 200 MCG Oral Tablet	PSN	f15b41bd-ed36-4908-aba5-f0a019b7a26e	6
317128	misoprostol 0.2 MG Oral Tablet	SCD	f15b41bd-ed36-4908-aba5-f0a019b7a26e	6
317128	misoprostol 200 MCG Oral Tablet	SY	f15b41bd-ed36-4908-aba5-f0a019b7a26e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12634-502-45	12634050245	45 TABLET in 1 BOTTLE (12634-502-45)	45 tablet	2009-12-27	0000-00-00	No	No	Current