FDA.reportPublic FDA data

NDC 64896-509-01 - BREKIYA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
64896-509
Requested NDC
64896-509-01
Package NDCs from labels
64896-509-01, 64896-509-02
Manufacturer
Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals Private Limited
Effective date
2025-10-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BREKIYA - Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals Private LimitedAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals Private Limited2025-10-04HUMAN PRESCRIPTION DRUG LABEL

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 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

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

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 39 of 162 · 3,234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLMY IMPORTS USA LLC4dd01f13-5ea3-7744-e063-6294a90a124f2026-03-24WarningsExact identifier
unii: 3K9958V90M
DIHYDROERGOTAMINE MESYLATEDIHYDROERGOTAMINE MESYLATESomerset Therapeutics, LLCc8ffdc19-a90d-453c-b094-2347e116b4052026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 81AXN7R2QT
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa1aed-d763-2098-e063-6394a90a704b2026-03-23WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa4b88-0ea3-2143-e063-6294a90a69ce2026-03-23WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc68be-558b-03f0-e063-6394a90aa90d2026-03-23WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc8688-f34b-1178-e063-6394a90a0e672026-03-23WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da93596-ec59-1e56-e063-6394a90afceb2026-03-22WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da951ff-37fe-4ca4-e063-6394a90a4baf2026-03-22WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da9cb12-3aaf-c0f9-e063-6394a90ae4a42026-03-22WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da8a7b6-d147-87c3-e063-6394a90a784c2026-03-22WarningsExact identifier
unii: 3K9958V90M
SMART CARE HOT WHEELS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.de908bc4-5c4b-4cd1-8c47-1489e957e8182026-03-20WarningsExact identifier
unii: 3K9958V90M
ALCOHOL PREP AWABSISOPROPYL ALCOHOL PATCHHenan Bingqing Yujie wipes Co., LTD2e67e417-4dba-73a2-e063-6294a90aa4b22026-03-20WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.50ed03d9-88d1-4930-9c7d-62082bf8ce952026-03-20WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MADRID MUSEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5cecf6-c232-6cd9-e063-6394a90a03e92026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VALENCIA VIBESALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5de4d6-4c58-f393-e063-6294a90a323a2026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MALLORCA BREEZEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5e50de-62fd-f9e9-e063-6394a90af0bd2026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MAR BELLAALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d6005d9-5d4d-033e-e063-6294a90ad36f2026-03-19WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hand sanitizerHAND SANITIZERShenzhen yuehaotong Technology Co., Ltd4d482f95-e192-3fef-e063-6294a90a6a402026-03-18WarningsExact identifier
unii: 3K9958V90M
Avant 70% Alcohol GelALCOHOLB4 Soap LLC241f4334-2e88-4f7b-a0c7-c93da9f5086c2026-03-18WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.