Dihydroergotamine Mesylate Nasal

Product NDC: 69097-503
11-digit product format: 690970503
Labeler code: 69097
Product ID: 69097-503_68a5f507-1f3a-412d-8321-1e8d74cc31bc
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: 2020-05-23
Substance: DIHYDROERGOTAMINE MESYLATE
Active strength: 4 mg/mL
Pharmacologic classes: Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dihydroergotamine Mesylate Nasal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIHYDROERGOTAMINE MESYLATE	4 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
861668	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
1ecb2311-eee3-4230-a019-a3496308cff1	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
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2053edd2-6ad3-4897-ba63-817235bdab3c	Product name	2	20220309
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69097-503-27	2024-01-31	C162847	48780-1	1030e365-4b6a-111a-e063-dadaa90a10e2	Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL
69097-503-31	2024-01-31	C162847	48780-1	1030e365-4b6a-111a-e063-dadaa90a10e2	Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69097-503-27	Dihydroergotamine Mesylate Nasal	8 in 1 KIT	SPRAY, METERED	8	10
69097-503-27	Dihydroergotamine Mesylate Nasal	1 mL in 1 VIAL	SPRAY, METERED	1	10
69097-503-31	Dihydroergotamine Mesylate Nasal	1 mL in 1 VIAL	SPRAY, METERED	1	10
69097-503-31	Dihydroergotamine Mesylate Nasal	1 in 1 KIT	SPRAY, METERED	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-503-27	ML - Milliliter	69097-503	5722f82a-e23f-467f-9fdd-13497b38bff6	1	2020-06-05
69097-503-31	ML - Milliliter	69097-503	1045b8ad-e563-4d8e-a9ad-61185f7712e7	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-503	DIHYDROERGOTAMINE MESYLATE NASAL SPRAY, METERED [CIPLA USA INC.]	9	Current NDC, Legacy NDC, 4 package rows	20240131_1ecb2311-eee3-4230-a019-a3496308cff1.zip

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 ndc (product): 69097-503

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
861668	dihydroergotamine mesylate 4 MG/mL Metered Dose Nasal Spray	PSN	1ecb2311-eee3-4230-a019-a3496308cff1	10
861668	dihydroergotamine mesylate 0.5 MG/ACTUAT Metered Dose Nasal Spray	SCD	1ecb2311-eee3-4230-a019-a3496308cff1	10
861668	DHE Mesylate 0.5 MG/ACTUAT Metered Dose Nasal Spray	SY	1ecb2311-eee3-4230-a019-a3496308cff1	10
861668	dihydroergotamine mesylate 0.5 MG/ACTUAT (4 MG/ML) Metered Dose Nasal Spray	SY	1ecb2311-eee3-4230-a019-a3496308cff1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-503-27	69097050327	8 VIAL in 1 KIT (69097-503-27) / 1 mL in 1 VIAL	8 vial	2020-05-23	0000-00-00	No	No	Current
69097-503-31	69097050331	1 VIAL in 1 KIT (69097-503-31) / 1 mL in 1 VIAL	1 vial	2020-05-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL	Cipla USA Inc. \| Mipharm SpA	2025-12-29	HUMAN PRESCRIPTION DRUG LABEL	10