Migergot

Product NDC: 75987-090
11-digit product format: 759870090
Labeler code: 75987
Product ID: 75987-090_eb79b0e8-07d8-478d-80a8-65bc9476e1b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ergotamine tartrate and caffeine
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Horizon Pharma Inc.
Application: ANDA086557
Marketing category: ANDA
Marketing start: 1983-10-30
Marketing end: 0000-00-00
Substance: ERGOTAMINE TARTRATE; CAFFEINE
Active strength: 2 mg/1; mg/1
Pharmacologic classes: Ergotamine Derivative [EPC],Ergotamines [CS],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	75987-090		I	Inactivated by FDA		2026-08-17
excluded package	package	75987-090	75987-090-11	I	Inactivated by FDA		2026-08-17

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 · 42 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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`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	75987-090-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75987-090-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75987-090-11	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75987-090-11	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	75987-090-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	75987-090-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	75987-090-11	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	75987-090-11	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	75987-090-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	75987-090-11	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A086557-001	MIGERGOT	CAFFEINE; ERGOTAMINE TARTRATE	100MG;2MG	SUPPOSITORY / RECTAL		RLD, RS	1983-10-04

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RS	1983-10-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086557-001	MIGERGOT	100MG;2MG	SUPPOSITORY / RECTAL	RLD, RS	1983-10-04	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
32fd258b-9140-42bc-be18-18756be615a0	Product name	1	20170614
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75987-090-11	2020-01-31	C162847	48780-1	9d75b9d0-1060-f424-e053-dadaa90a57ce	Ergotamine Tartrate and Caffeine Suppositories USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75987-090-11	Migergot	12 in 1 CARTON	SUPPOSITORY	12		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75987-090-11	EA - Each	75987-090	17887b26-11d4-4238-b6d0-53349353e1bd	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75987-090	MIGERGOT (ERGOTAMINE TARTRATE AND CAFFEINE) SUPPOSITORY [HORIZON PHARMA INC.]	2	Legacy NDC, 1 package rows	20180129_4ae331e0-009a-477e-8408-6118dc620634.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIGERGOT	ERGOTAMINE TARTRATE AND CAFFEINE	Cosette Pharmaceuticals, Inc.	3a31ad0c-7bdd-544b-f5df-a99d04cf541c	2022-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086557 application number: ANDA086557

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MRU5XH3B48	ERGOTAMINE TARTRATE	379-79-3	ERGOTAMINE TARTRATE
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1293508	ergotamine tartrate 2 MG / caffeine 100 MG Rectal Suppository	PSN	4ae331e0-009a-477e-8408-6118dc620634	2
1293639	MIGERGOT 2 MG / 100 MG Rectal Suppository	PSN	4ae331e0-009a-477e-8408-6118dc620634	2
1293639	caffeine 100 MG / ergotamine tartrate 2 MG Rectal Suppository [Migergot]	SBD	4ae331e0-009a-477e-8408-6118dc620634	2
1293508	caffeine 100 MG / ergotamine tartrate 2 MG Rectal Suppository	SCD	4ae331e0-009a-477e-8408-6118dc620634	2
1293639	Migergot (caffeine 100 MG / ergotamine tartrate 2 MG) Rectal Suppository	SY	4ae331e0-009a-477e-8408-6118dc620634	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
75987-090-11	75987009011	12 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ergotamine Tartrate and Caffeine Suppositories USP	Horizon Pharma Inc.	2018-01-30	HUMAN PRESCRIPTION DRUG LABEL	2