FDA.reportPublic FDA data

ATZUMI

Product NDC
76978-101
11-digit product format
769780101
Labeler code
76978
Product ID
76978-101_3b0b0981-a681-4c0c-91fb-b662277e92ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIHYDROERGOTAMINE MESYLATE
Dosage form
POWDER
Route
NASAL
Labeler
Satsuma Pharmaceuticals, Inc.
Application
NDA217901
Marketing category
NDA
Marketing start
2025-04-30
Substance
DIHYDROERGOTAMINE MESYLATE
Active strength
5.2 mg/1
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217901-001ATZUMIDIHYDROERGOTAMINE MESYLATEEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-30

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217901-001125942732033-09-24Drug product2026-05-04
N217901-001107922532037-08-04Drug product2025-05-23
N217901-001118723142037-08-04Drug product2025-05-23
N217901-001107585322039-12-11Drug product2025-05-23
N217901-001122631622039-12-11Drug product2025-05-23
N217901-001117449672041-10-12Drug product2025-05-23
N217901-001121027542041-10-12Drug product2025-05-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217901-001NP2028-04-30

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 UTC2026-02N217901-001ATZUMIEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001ATZUMIEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N217901-001ATZUMIEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001ATZUMIEQ 5.2MG BASEPOWDER / NASALRLD, RS2025-04-30a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217901-001107922532037-08-04Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001118723142037-08-04Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001107585322039-12-11Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001122631622039-12-11Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001117449672041-10-12Drug product2025-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217901-001121027542041-10-12Drug product2025-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001107922532037-08-04Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001118723142037-08-04Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001107585322039-12-11Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001122631622039-12-11Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001117449672041-10-12Drug product2025-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001121027542041-10-12Drug product2025-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N217901-001107922532037-08-04Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001118723142037-08-04Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001107585322039-12-11Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001122631622039-12-11Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001117449672041-10-12Drug product2025-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217901-001121027542041-10-12Drug product2025-05-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001125942732033-09-24Drug product2026-05-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001107922532037-08-04Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001118723142037-08-04Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001107585322039-12-11Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001122631622039-12-11Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001117449672041-10-12Drug product2025-05-23a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001121027542041-10-12Drug product2025-05-23a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N217901-001NP2028-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217901-001NP2028-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N217901-001NP2028-04-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217901-001NP2028-04-30a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIHYDROERGOTAMINE MESYLATE5.2 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2714187Internal RxNorm lookup
2714192Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0982a44a-dc0c-75c0-e063-6394a90a6d6cAvailable 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
2053edd2-6ad3-4897-ba63-817235bdab3cProduct name220220309
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76978-101-08ATZUMI1 in 1 BOTTLE, UNIT-DOSEPOWDER12
76978-101-08ATZUMI8 in 1 CARTONPOWDER82
76978-101-11ATZUMI1 in 1 BOTTLE, UNIT-DOSEPOWDER12
76978-101-11ATZUMI1 in 1 CARTONPOWDER12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76978-101ATZUMI (DIHYDROERGOTAMINE MESYLATE) POWDER [SATSUMA PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20250515_0982a44a-dc0c-75c0-e063-6394a90a6d6c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATZUMIDIHYDROERGOTAMINE MESYLATESatsuma Pharmaceuticals, Inc.0982a44a-dc0c-75c0-e063-6394a90a6d6c2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217901
application number: NDA217901
ndc (product): 76978-101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2714192Atzumi 5.2 MG Nasal PowderPSN0982a44a-dc0c-75c0-e063-6394a90a6d6c2
2714187dihydroergotamine 5.2 MG Nasal PowderPSN0982a44a-dc0c-75c0-e063-6394a90a6d6c2
2714192dihydroergotamine 5.2 MG Nasal Powder [Atzumi]SBD0982a44a-dc0c-75c0-e063-6394a90a6d6c2
2714187dihydroergotamine 5.2 MG Nasal PowderSCD0982a44a-dc0c-75c0-e063-6394a90a6d6c2
2714192Atzumi 5.2 MG Nasal PowderSY0982a44a-dc0c-75c0-e063-6394a90a6d6c2
2714187DHE 5.2 MG Nasal PowderSY0982a44a-dc0c-75c0-e063-6394a90a6d6c2
2714192DHE 5.2 MG Nasal Powder [Atzumi]SY0982a44a-dc0c-75c0-e063-6394a90a6d6c2
2714187dihydroergotamine 5.2 MG (equivalent to dihydroergotamine mesylate 6 MG) Nasal PowderSY0982a44a-dc0c-75c0-e063-6394a90a6d6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76978-101-08769780101088 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSE2025-04-30NoNoCurrent
76978-101-11769780101111 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE2025-04-30NoNoCurrent