FDA.reportPublic FDA data

Dihydroergotamine mesylate

Product NDC
72888-096
11-digit product format
728880096
Labeler code
72888
Product ID
72888-096_47c7c595-73f1-4f7c-e063-6394a90afd8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dihydroergotamine mesylate
Dosage form
SPRAY
Route
NASAL
Labeler
Advagen Pharma Ltd
Application
ANDA216881
Marketing category
ANDA
Marketing start
2023-06-23
Substance
DIHYDROERGOTAMINE MESYLATE
Active strength
4 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216881-001DIHYDROERGOTAMINE MESYLATEDIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216881-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-228072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216881-001DIHYDROERGOTAMINE MESYLATE0.5MG/SPRAYSPRAY, METERED / NASALAB2023-06-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216881-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216881-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216881-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216881-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216881-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216881-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216881-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216881-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216881-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216881-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216881-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216881-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216881-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216881-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216881-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216881-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216881-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216881-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216881-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216881-001AB1a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216881-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIHYDROERGOTAMINE MESYLATE4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81AXN7R2QTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65f8c60d-9213-48ac-8233-acc5d44548f4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c9a995-456f-4920-9be6-19f388510405Product name120260303
0dc20644-8d0b-4adf-9269-872bb65fd7fbProduct name320251205
803e1b3a-35b6-0bc8-229b-d2f7e8a7ffd4Product name520250516
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2053edd2-6ad3-4897-ba63-817235bdab3cProduct name220220309
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-096-18Dihydroergotamine mesylate1 mL in 1 VIAL, GLASSSPRAY14
72888-096-18Dihydroergotamine mesylate1 in 1 KITSPRAY14
72888-096-19Dihydroergotamine mesylate8 in 1 KITSPRAY84
72888-096-34Dihydroergotamine mesylate1 mL in 1 VIAL, GLASSSPRAY14
72888-096-34Dihydroergotamine mesylate1 in 1 KITSPRAY14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-096-18ML - Milliliter72888-0966a0135de-d143-405e-87d8-3b46eb20687612023-08-08
72888-096-19ML - Milliliter72888-09654a6a472-642f-4afd-b01b-08feee1d55a712023-08-08
72888-096-34ML - Milliliter72888-09600abbdaf-edb6-4033-8ea1-45496e495c8812023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-096DIHYDROERGOTAMINE MESYLATE SPRAY [ADVAGEN PHARMA LTD]3Current NDC, 5 package rows20240907_65f8c60d-9213-48ac-8233-acc5d44548f4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dihydroergotamine mesylateDIHYDROERGOTAMINE MESYLATEAdvagen Pharma Ltd65f8c60d-9213-48ac-8233-acc5d44548f42026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216881
application number: ANDA216881
ndc (product): 72888-096
Dihydroergotamine mesylateDIHYDROERGOTAMINE MESYLATETrifluent Pharma, LLC4cb78f66-6ccf-4ac7-8599-e199f6995f052025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216881
application number: ANDA216881

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861668dihydroergotamine mesylate 4 MG/mL Metered Dose Nasal SprayPSN65f8c60d-9213-48ac-8233-acc5d44548f44
861668dihydroergotamine mesylate 0.5 MG/ACTUAT Metered Dose Nasal SpraySCD65f8c60d-9213-48ac-8233-acc5d44548f44
861668DHE Mesylate 0.5 MG/ACTUAT Metered Dose Nasal SpraySY65f8c60d-9213-48ac-8233-acc5d44548f44
861668dihydroergotamine mesylate 0.5 MG/ACTUAT (4 MG/ML) Metered Dose Nasal SpraySY65f8c60d-9213-48ac-8233-acc5d44548f44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-096-18728880096181 mL in 1 VIAL, GLASS1 mlHistorical
72888-096-19728880096198 KIT in 1 KIT (72888-096-19) / 1 VIAL, GLASS in 1 KIT (72888-096-18) / 1 mL in 1 VIAL, GLASS8 kit2023-06-23NoNoCurrent
72888-096-34728880096341 VIAL, GLASS in 1 KIT (72888-096-34) / 1 mL in 1 VIAL, GLASS2023-06-23NoNoCurrent