Dihydroergotamine Mesylate

Product NDC: 71357-013
11-digit product format: 713570013
Labeler code: 71357
Product ID: 71357-013_52ba951e-772f-ca73-e063-6294a90a5fd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dihydroergotamine Mesylate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Milla Pharmaceuticals Inc.
Application: ANDA212046
Marketing category: ANDA
Marketing start: 2021-09-30
Substance: DIHYDROERGOTAMINE MESYLATE
Active strength: 1 mg/mL
Pharmacologic classes: Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dihydroergotamine Mesylate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIHYDROERGOTAMINE MESYLATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
81AXN7R2QT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861672	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b464a64d-b150-4f6b-b3df-e486a41294d7	Available on FDA.report

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
2053edd2-6ad3-4897-ba63-817235bdab3c	Product name	2	20220309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71357-013-01	Dihydroergotamine Mesylate	1 mL in 1 AMPULE	INJECTION, SOLUTION	1	2
71357-013-05	Dihydroergotamine Mesylate	5 in 1 CARTON	INJECTION, SOLUTION	5	2
71357-013-10	Dihydroergotamine Mesylate	10 in 1 CARTON	INJECTION, SOLUTION	10	2

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 ndc (product): 71357-013
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861672	dihydroergotamine mesylate 1 MG in 1 ML Injection	PSN	b464a64d-b150-4f6b-b3df-e486a41294d7	2
861672	1 ML dihydroergotamine mesylate 1 MG/ML Injection	SCD	b464a64d-b150-4f6b-b3df-e486a41294d7	2
861672	1 ML DHE Mesylate 1 MG/ML Injection	SY	b464a64d-b150-4f6b-b3df-e486a41294d7	2
861672	dihydroergotamine mesylate 1 MG per 1 ML Injection	SY	b464a64d-b150-4f6b-b3df-e486a41294d7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71357-013-01	71357001301	1 mL in 1 AMPULE	1 ml				Historical
71357-013-05	71357001305	5 AMPULE in 1 CARTON (71357-013-05) / 1 mL in 1 AMPULE (71357-013-01)	5 ampule	2026-05-22	No	No	Current
71357-013-10	71357001310	10 AMPULE in 1 CARTON (71357-013-10) / 1 mL in 1 AMPULE (71357-013-01)	10 ampule	2026-05-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dihydroergotamine Mesylate Injection, USP Rx only	Milla Pharmaceuticals Inc.	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	2