Misoprostol

Product NDC: 0904-6807
Requested package NDC: 0904-6807-61
11-digit product format: 009046807
Labeler code: 0904
Product ID: 0904-6807_07e58d46-ce43-4c8f-810c-3361a41e5a4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Misoprostol
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA091667
Marketing category: ANDA
Marketing start: 2012-07-25
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: 2022-12-31
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	0904-6807	0904-6807-61	D	Discontinued by firm		2026-08-03

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 · 12 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…`

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
A091667-001	MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET / ORAL			2012-07-25
A091667-002	MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET / ORAL			2012-07-25

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2012-07-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2012-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL	BX	2012-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL	BX	2012-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL	BX	2012-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL	BX	2012-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL	BX	2012-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL	BX	2012-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2012-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2012-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL	BX	2012-07-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL	BX	2012-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091667-001	MISOPROSTOL	0.1MG	TABLET / ORAL	BX	2012-07-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091667-002	MISOPROSTOL	0.2MG	TABLET / ORAL	BX	2012-07-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091667-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091667-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091667-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091667-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091667-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091667-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091667-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091667-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091667-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091667-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091667-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091667-002	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091667-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091667-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091667-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091667-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091667-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091667-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091667-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091667-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091667-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091667-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091667-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091667-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091667-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091667-002	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A091667-001	BX	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091667-002	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091667-001	BX	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091667-002	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091667-001	BX	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091667-002	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091667-001	BX	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091667-002	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091667-001	BX	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091667-002	BX	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6807-61	EA - Each	0904-6807	87db9a4e-a1a6-4e24-a5cb-5952a4249b34	1	2021-11-09

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	NuCare Pharmaceuticals,Inc.	8642b8e4-d1bb-f12a-e053-2a91aa0a14bf	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091667 application number: ANDA091667
Misoprostol	MISOPROSTOL	PharmPak, Inc.	b07b3dfc-1cb5-484c-be11-8d14c89c794f	2022-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091667 application number: ANDA091667
Misoprostol	MISOPROSTOL	Lupin Pharmaceuticals,Inc.	14f73ae3-7d8d-4d10-b668-8bd5adf8032c	2020-12-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091667 application number: ANDA091667
Misoprostol	MISOPROSTOL	Novel Laboratories, Inc.	a46d05a2-5014-40ff-8f1b-9eca1b0aff3a	2020-12-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091667 application number: ANDA091667

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
0904-6807-61	00904680761	100 BLISTER PACK in 1 CARTON (0904-6807-61) > 1 TABLET in 1 BLISTER PACK	100 blister pack	2012-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Misoprostol Tablets Lupin Pharmaceuticals, Inc	Major Pharmaceuticals \| Novel Laboratories, Inc.	2021-09-29	HUMAN PRESCRIPTION DRUG LABEL	1