Dihydroergotamine Mesylate Nasal

Product NDC: 69097-740
Requested package NDC: 69097-740-31
11-digit product format: 690970740
Labeler code: 69097
Product ID: 69097-740_c6908afb-ab07-4962-bb1c-5e671e1d2c54
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dihydroergotamine Mesylate Nasal
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Cipla USA 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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69097-740	69097-740-31	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 · 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 · 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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69097-740-31	2024-01-31	C162847	48780-1	1030e365-44e0-111a-e063-dadaa90a10e2	Dihydroergotamine Mesylate Nasal Spray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-740-31	ML - Milliliter	69097-740	2f17c7dc-0611-43b6-89f7-907f601d48ee	1	2021-01-08

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
69097-740-31	69097074031	1 VIAL in 1 KIT (69097-740-31) > 1 mL in 1 VIAL	1 vial	2020-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dihydroergotamine Mesylate Nasal Spray	Cipla USA Inc. \| Mipharm S.p.A., Italy	2022-05-31	HUMAN PRESCRIPTION DRUG LABEL	3