Migranal

Product NDC: 0187-0245
11-digit product format: 001870245
Labeler code: 0187
Product ID: 0187-0245_a98c05bc-6520-4e79-ada5-bed743f5dc91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dihydroergotamine mesylate
Dosage form: SPRAY
Route: NASAL
Labeler: Bausch Health US, LLC
Application: NDA020148
Marketing category: NDA
Marketing start: 1997-12-08
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0187-0245		D	Discontinued by firm	2026-08-11
excluded package	package	0187-0245	0187-0245-01	D	Discontinued by firm	2026-08-11
excluded package	package	0187-0245	0187-0245-03	D	Discontinued by firm	2026-08-11
excluded package	package	0187-0245	0187-0245-04	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, 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	0187-0245-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-0245-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-0245-03	`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	0187-0245-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-0245-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-0245-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-0245-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-0245-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-0245-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-0245-03	`cdf11ea48f46…`	`ba0047e9e063…`

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
N020148-001	MIGRANAL	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020148-001	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	1997-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	1997-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	1997-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	1997-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020148-001	MIGRANAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	1997-12-08	`cb3db0bc1861…`

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	N020148-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020148-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020148-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020148-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020148-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020148-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020148-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020148-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020148-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020148-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020148-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020148-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020148-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020148-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020148-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020148-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020148-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N020148-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020148-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020148-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020148-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020148-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020148-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020148-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020148-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020148-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020148-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020148-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020148-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020148-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020148-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020148-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020148-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020148-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020148-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020148-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020148-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-0245-03	ML - Milliliter	0187-0245	53ecc83a-b360-4024-af29-d64f7630df04	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
dihydroergotamine mesylate	ACTIVE INGREDIENT	81AXN7R2QT	MIGRANAL (DIHYDROERGOTAMINE MESYLATE) SPRAY [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	5
dihydroergotamine	ACTIVE MOIETY	436O5HM03C	MIGRANAL (DIHYDROERGOTAMINE MESYLATE) SPRAY [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	5
Anhydrous Dextrose	INACTIVE INGREDIENT	5SL0G7R0OK	MIGRANAL (DIHYDROERGOTAMINE MESYLATE) SPRAY [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	5
Caffeine	INACTIVE INGREDIENT	3G6A5W338E	MIGRANAL (DIHYDROERGOTAMINE MESYLATE) SPRAY [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	5
Carbon Dioxide	INACTIVE INGREDIENT	142M471B3J	MIGRANAL (DIHYDROERGOTAMINE MESYLATE) SPRAY [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	5
Water	INACTIVE INGREDIENT	059QF0KO0R	MIGRANAL (DIHYDROERGOTAMINE MESYLATE) SPRAY [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	5

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	DIHYDROERGOTAMINE MESYLATE	Oceanside Pharmaceuticals	977de209-c53a-4cb4-9f3f-1e850600a9dc	2025-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020148 application number: NDA020148

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
0187-0245-01	00187024501	1 VIAL in 1 KIT (0187-0245-01) > 1 mL in 1 VIAL	1 vial	1997-12-08	0000-00-00	Yes	No	Current
0187-0245-03	00187024503	8 VIAL in 1 KIT (0187-0245-03) > 1 mL in 1 VIAL	8 vial	1997-12-08	0000-00-00	No	No	Current
0187-0245-04	00187024504	1 VIAL in 1 KIT (0187-0245-04) > 1 mL in 1 VIAL	1 vial	1997-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MIGRANAL ® (dihydroergotamine mesylate) Nasal Spray	Bausch Health US, LLC \| Mipharm SpA	2025-03-06	HUMAN PRESCRIPTION DRUG LABEL	17