FDA.reportPublic FDA data

BREKIYA

Product NDC
64896-509
11-digit product format
648960509
Labeler code
64896
Product ID
64896-509_1d8fa8b1-75e6-42af-863d-a775791da7a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dihydroergotamine Mesylate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amneal Pharmaceuticals LLC
Application
NDA215400
Marketing category
NDA
Marketing start
2025-05-16
Substance
DIHYDROERGOTAMINE MESYLATE
Active strength
1 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215400-001BREKIYA (AUTOINJECTOR)DIHYDROERGOTAMINE MESYLATE1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-14

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215400-001105320492039-02-26Drug product2025-05-28
N215400-001113049422039-02-26Drug product2025-05-28
N215400-001118195012039-02-26U-41882025-05-28
N215400-001118195012039-02-26U-8482025-05-28
N215400-001125333512039-02-26Drug product2026-02-26
N215400-001115410432039-03-20Drug product2026-05-26
N215400-001123297492039-05-27U-2718Drug product2026-05-26
N215400-001123297492039-05-27U-4508Drug product2026-05-26
N215400-001110837122039-06-30U-2718Drug product2026-05-26
N215400-001110837122039-06-30U-4508Drug product2026-05-26
N215400-001124149412039-08-24Drug product2026-05-26

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 UTC2026-02N215400-001BREKIYA (AUTOINJECTOR)1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001BREKIYA (AUTOINJECTOR)1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N215400-001BREKIYA (AUTOINJECTOR)1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-146a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001BREKIYA (AUTOINJECTOR)1MG/MLSOLUTION / SUBCUTANEOUSRLD, RS2025-05-14a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215400-001105320492039-02-26Drug product2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215400-001113049422039-02-26Drug product2025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215400-001118195012039-02-26U-8482025-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215400-001118195012039-02-26U-41882025-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001105320492039-02-26Drug product2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001113049422039-02-26Drug product2025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001118195012039-02-26U-8482025-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215400-001118195012039-02-26U-41882025-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215400-001105320492039-02-26Drug product2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215400-001113049422039-02-26Drug product2025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215400-001118195012039-02-26U-8482025-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215400-001118195012039-02-26U-41882025-05-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001105320492039-02-26Drug product2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001113049422039-02-26Drug product2025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001118195012039-02-26U-8482025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001118195012039-02-26U-41882025-05-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001125333512039-02-26Drug product2026-02-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001115410432039-03-20Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001123297492039-05-27U-2718Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001123297492039-05-27U-4508Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001110837122039-06-30U-2718Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001110837122039-06-30U-4508Drug product2026-05-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215400-001124149412039-08-24Drug product2026-05-26a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
BREKIYA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIHYDROERGOTAMINE MESYLATE1 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2714308Internal RxNorm lookup
2714315Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cdbf5619-767f-4165-aec2-17bdd92d9ca2Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64896-509-01BREKIYA1 mL in 1 SYRINGEINJECTION12
64896-509-02BREKIYA1 in 1 POUCHINJECTION12
64896-509-02BREKIYA4 in 1 CARTONINJECTION42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64896-509-01ML - Milliliter64896-5092febacb7-4e95-44bb-a8eb-95f060a09cd412025-10-14
64896-509-02ML - Milliliter64896-5092f210246-2a19-4152-822c-454c4bf1dee312025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64896-509BREKIYA (DIHYDROERGOTAMINE MESYLATE) INJECTION [AMNEAL PHARMACEUTICALS LLC]1Current NDC, 3 package rows20250519_cdbf5619-767f-4165-aec2-17bdd92d9ca2.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
BREKIYADIHYDROERGOTAMINE MESYLATEAmneal Pharmaceuticals LLCcdbf5619-767f-4165-aec2-17bdd92d9ca22025-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 215400
application number: NDA215400
ndc (product): 64896-509

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2714315brekiya 1 MG in 1 ML Auto-InjectorPSNcdbf5619-767f-4165-aec2-17bdd92d9ca22
2714308dihydroergotamine mesylate 1 MG in 1 ML Auto-InjectorPSNcdbf5619-767f-4165-aec2-17bdd92d9ca22
27143151 ML dihydroergotamine mesylate 1 MG/ML Auto-Injector [Brekiya]SBDcdbf5619-767f-4165-aec2-17bdd92d9ca22
27143081 ML dihydroergotamine mesylate 1 MG/ML Auto-InjectorSCDcdbf5619-767f-4165-aec2-17bdd92d9ca22
27143151 ML Brekiya 1 MG/ML Auto-InjectorSYcdbf5619-767f-4165-aec2-17bdd92d9ca22
27143081 ML DHE mesylate 1 MG/ML Auto-InjectorSYcdbf5619-767f-4165-aec2-17bdd92d9ca22
27143151 ML DHE mesylate 1 MG/ML Auto-Injector [Brekiya]SYcdbf5619-767f-4165-aec2-17bdd92d9ca22
2714315Brekiya 1 MG (equivalent to dihydroergotamine 0.86 MG) per 1 ML Auto-InjectorSYcdbf5619-767f-4165-aec2-17bdd92d9ca22
2714308dihydroergotamine mesylate 1 MG (equivalent to dihydroergotamine 0.86 MG) per 1 ML Auto-InjectorSYcdbf5619-767f-4165-aec2-17bdd92d9ca22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64896-509-01648960509011 mL in 1 SYRINGE1 mlHistorical
64896-509-02648960509024 POUCH in 1 CARTON (64896-509-02) / 1 SYRINGE in 1 POUCH / 1 mL in 1 SYRINGE (64896-509-01) 4 pouch2025-05-16NoNoCurrent