Dihydroergotamine Mesylate

Product NDC: 82454-0411
11-digit product format: 824540411
Labeler code: 82454
Product ID: 82454-0411_d460013a-0fb7-e3ae-e053-2a95a90a1f0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dihydroergotamine Mesylate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: CENEXI HSC
Application: ANDA212046
Marketing category: ANDA
Marketing start: 2020-04-14
Marketing end: 0000-00-00
Substance: DIHYDROERGOTAMINE MESYLATE
Active strength: 1 mg/mL
Pharmacologic classes: Ergotamines [CS],Ergotamine Derivative [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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
A212046-001	DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP		2020-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212046-001	AP

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	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212046-001	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	AP	2020-01-07	`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	A212046-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212046-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212046-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212046-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212046-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212046-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212046-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212046-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212046-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212046-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212046-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212046-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212046-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212046-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212046-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212046-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212046-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212046-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212046-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212046-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212046-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212046-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212046-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212046-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212046-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212046-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212046-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212046-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212046-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212046-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212046-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212046-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212046-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212046-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212046-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212046-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212046-001	AP	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Milla Pharmaceuticals Inc.	b464a64d-b150-4f6b-b3df-e486a41294d7	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212046 application number: ANDA212046
Dihydroergotamine Mesylate	DIHYDROERGOTAMINE MESYLATE	Provepharm Inc.	40b9ba9e-436e-444e-b078-01b12bb57ea7	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212046 application number: ANDA212046

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
82454-0411-1	82454041101	5 AMPULE in 1 CARTON (82454-0411-1) > 1 mL in 1 AMPULE (82454-0411-0)	5 ampule	2020-04-14	0000-00-00	No	No	Current
82454-0411-2	82454041102	10 AMPULE in 1 CARTON (82454-0411-2) > 1 mL in 1 AMPULE (82454-0411-0)	10 ampule	2020-04-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dihydroergotamine Mesylate Injection, USP	CENEXI HSC \| CENEXI - FTY	2021-12-30	HUMAN PRESCRIPTION DRUG LABEL	1