Dihydroergotamine Mesylate Nasal

Product NDC: 76282-680
11-digit product format: 762820680
Labeler code: 76282
Product ID: 76282-680_1df146fa-981e-49fb-8c64-5227ead000c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dihydroergotamine Mesylate Nasal
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Exelan Pharmaceuticals, Inc.
Application: ANDA212907
Marketing category: ANDA
Marketing start: 2020-12-11
Marketing end: 0000-00-00
Substance: DIHYDROERGOTAMINE MESYLATE
Active strength: 4 mg/mL
Pharmacologic classes: Ergotamines [CS],Ergotamine Derivative [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76282-680		D	Discontinued by firm	2026-08-11
excluded package	package	76282-680	76282-680-43	D	Discontinued by firm	2026-08-11
excluded package	package	76282-680	76282-680-44	D	Discontinued by firm	2026-08-11

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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76282-680-43	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76282-680-44	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76282-680-44	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76282-680-43	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76282-680-44	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76282-680-43	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76282-680-44	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76282-680-43	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76282-680-44	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76282-680-43	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76282-680-44	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76282-680-43	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76282-680-44	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76282-680-43	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76282-680-44	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76282-680-43	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76282-680-44	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76282-680-43	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76282-680-44	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76282-680-43	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76282-680-44	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76282-680-43	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76282-680-44	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76282-680-43	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76282-680-44	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76282-680-43	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76282-680-44	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76282-680-43	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76282-680-44	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76282-680-43	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76282-680-43	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76282-680-44	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76282-680-43	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76282-680-44	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76282-680-43	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76282-680-44	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A212907-001	DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB		2020-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212907-001	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.

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	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212907-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212907-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212907-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212907-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212907-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212907-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212907-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212907-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212907-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212907-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212907-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212907-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212907-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212907-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212907-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212907-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212907-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212907-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212907-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212907-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212907-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212907-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212907-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212907-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212907-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212907-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212907-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212907-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212907-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212907-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212907-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212907-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212907-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212907-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212907-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212907-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212907-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212907-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A212907-001	CGT	2020-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212907-001	CGT	2020-11-19	`c0c555d07b60…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
45c9a995-456f-4920-9be6-19f388510405	Product name	1	20260303
0dc20644-8d0b-4adf-9269-872bb65fd7fb	Product name	3	20251205
803e1b3a-35b6-0bc8-229b-d2f7e8a7ffd4	Product name	5	20250516
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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2053edd2-6ad3-4897-ba63-817235bdab3c	Product name	2	20220309
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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, Related label table
NDC	Effective	Related label
76282-680-43	2025-11-14	Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL
76282-680-44	2025-11-14	Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL
76282-680-43	2022-01-28	Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL
76282-680-44	2022-01-28	Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-680-43	ML - Milliliter	76282-680	886b1e19-4268-4502-bf6c-fafe333e687e	1	2021-04-08
76282-680-44	ML - Milliliter	76282-680	e2c54213-9d19-4683-ad79-3a83581f4968	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-680	DIHYDROERGOTAMINE MESYLATE NASAL SPRAY, METERED [EXELAN PHARMACEUTICALS, INC.]	2	Legacy NDC	20201211_ed1b7598-1778-4c0e-abe0-1ee96c728aac.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
Dihydroergotamine Mesylate Nasal	DIHYDROERGOTAMINE MESYLATE NASAL	Cipla USA Inc.	1ecb2311-eee3-4230-a019-a3496308cff1	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212907 application number: ANDA212907

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
81AXN7R2QT	DIHYDROERGOTAMINE MESYLATE	6190-39-2	DIHYDROERGOTAMINE MESYLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-680-43	76282068043	1 VIAL in 1 KIT (76282-680-43) > 1 mL in 1 VIAL	1 vial	2020-12-11	0000-00-00	No	No	Current
76282-680-44	76282068044	8 VIAL, GLASS in 1 KIT (76282-680-44) > 1 mL in 1 VIAL, GLASS		2020-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL	Exelan Pharmaceuticals, Inc. \| Mipharm S.p.A., Italy	2020-12-10	HUMAN PRESCRIPTION DRUG LABEL	2