Dihydroergotamine Mesylate

Product NDC: 69238-1606
11-digit product format: 692381606
Labeler code: 69238
Product ID: 69238-1606_ab344498-3127-4482-8e64-e586dd291307
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dihydroergotamine
Dosage form: SPRAY
Route: NASAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA214105
Marketing category: ANDA
Marketing start: 2022-01-10
Marketing end: 0000-00-00
Substance: DIHYDROERGOTAMINE MESYLATE
Active strength: 4 mg/mL
Pharmacologic classes: Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	69238-1606		D	Discontinued by firm		2026-08-11
excluded package	package	69238-1606	69238-1606-8	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 · 30 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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`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	69238-1606-8	`1332a3947898…`	`d4bfe170f9cd…`

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
A214105-001	DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL			2022-01-04

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.

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	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	2022-01-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214105-001	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL		2022-01-04	`a50c72e98297…`

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	A214105-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214105-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214105-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214105-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214105-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214105-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214105-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214105-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214105-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214105-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214105-001	AB	1	`3f0d92c62455…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214105-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69238-1606-8	2026-01-15	C162847	48780-1	1030e365-10b3-111a-e063-dadaa90a10e2	Dihydroergotamine Mesylate Nasal Spray The solution used in dihydroergotamine mesylate nasal spray (4 mg/mL) is intended for intranasal use and must not be injected. Rx Only
69238-1606-8	2024-01-30	C162847	48780-1	1030e365-10b3-111a-e063-dadaa90a10e2	Dihydroergotamine Mesylate Nasal Spray The solution used in dihydroergotamine mesylate nasal spray (4 mg/mL) is intended for intranasal use and must not be injected. Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1606-1	ML - Milliliter	69238-1606	76e07d4e-713a-472c-9401-ef2cfc97e67c	1	2023-10-16
69238-1606-8	ML - Milliliter	69238-1606	9ecc97ad-a49e-42fd-a8a3-4527c493d11f	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1606	DIHYDROERGOTAMINE MESYLATE (DIHYDROERGOTAMINE) SPRAY [AMNEAL PHARMACEUTICALS NY LLC]	14	Legacy NDC	20221014_52ebf4f0-c126-4439-a5e3-430fe90a3d28.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
81AXN7R2QT	DIHYDROERGOTAMINE MESYLATE	6190-39-2	DIHYDROERGOTAMINE MESYLATE
436O5HM03C	DIHYDROERGOTAMINE	511-12-6	Dihydroergotamine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1606-8	69238160608	8 VIAL in 1 CARTON (69238-1606-8) > 1 mL in 1 VIAL (69238-1606-1)	8 vial	2022-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dihydroergotamine Mesylate	Amneal Pharmaceuticals NY LLC	2022-10-13	HUMAN PRESCRIPTION DRUG LABEL	14