Ergomar

Product NDC: 10802-1202
11-digit product format: 108021202
Labeler code: 10802
Product ID: 10802-1202_6ac058ea-d4f4-4fcd-83e1-5f2adb8652e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ergotamine Tartrate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: SUBLINGUAL
Labeler: Rosedale Therapeutics
Application: ANDA087693
Marketing category: ANDA
Marketing start: 2012-08-31
Marketing end: 0000-00-00
Substance: ERGOTAMINE TARTRATE
Active strength: 2 mg/1
Pharmacologic classes: Ergotamine Derivative [EPC],Ergotamines [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 39 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
2025-01-11 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	10802-1202-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10802-1202-3	`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	10802-1202-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10802-1202-3	`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	10802-1202-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10802-1202-3	`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	10802-1202-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10802-1202-3	`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	10802-1202-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10802-1202-3	`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	10802-1202-0	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10802-1202-3	`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	10802-1202-0	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10802-1202-3	`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	10802-1202-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10802-1202-3	`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	10802-1202-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10802-1202-3	`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	10802-1202-0	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10802-1202-3	`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	10802-1202-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10802-1202-3	`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	10802-1202-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10802-1202-3	`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	10802-1202-0	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10802-1202-3	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A087693-001	ERGOMAR	ERGOTAMINE TARTRATE	2MG	TABLET / SUBLINGUAL		RS	1983-02-24

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087693-001	ERGOMAR	2MG	TABLET / SUBLINGUAL	RS	1983-02-24	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10802-1202-0	2020-01-31	C162847	48780-1	9d75b9d0-b3f2-f424-e053-dadaa90a57ce	Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP)
10802-1202-3	2020-01-31	C162847	48780-1	9d75b9d0-b3f2-f424-e053-dadaa90a57ce	Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10802-1202-0	EA - Each	10802-1202	f55ef9b6-3068-4c8c-aa5d-920fea54ceb4	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ergotamine Tartrate	ACTIVE INGREDIENT	MRU5XH3B48	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
Ergotamine	ACTIVE MOIETY	PR834Q503T	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
Crospovidone	INACTIVE INGREDIENT	68401960MK	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
Peppermint	INACTIVE INGREDIENT	V95R5KMY2B	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1
Saccharin Sodium Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	ERGOMAR (ERGOTAMINE TARTRATE) TABLET, ORALLY DISINTEGRATING [ROSEDALE THERAPEUTICS]	1

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
Ergomar Sublingual	ERGOTAMINE TARTRATE	Pangea Pharmaceuticals LLC	a9582fdb-7ddd-4f69-aa7a-66247cdb8c92	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087693 application number: ANDA087693

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MRU5XH3B48	ERGOTAMINE TARTRATE	379-79-3	ERGOTAMINE TARTRATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP)	Rosedale Therapeutics \| Mikart, Inc.	2012-09-08	HUMAN PRESCRIPTION DRUG LABEL	1