FDA.reportPublic FDA data

NDC 10094-210-01 - SYMPAZAN

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
10094-210
Requested NDC
10094-210-01
Package NDCs from labels
10094-210-01, 10094-210-60
Manufacturer
Aquestive Therapeutics
Effective date
2025-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SYMPAZAN - Aquestive TherapeuticsAquestive Therapeutics2025-12-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10094-210-01SYMPAZAN1 in 1 POUCHFILM114
10094-210-60SYMPAZAN60 in 1 PACKAGEFILM6014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10094-210SYMPAZAN (CLOBAZAM) FILM [AQUESTIVE THERAPEUTICS]12Current NDC, Legacy NDC, 2 package rows20240316_5e3d8fcb-aa7d-4822-88fc-4f06264c3242.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10094-210-01EA - Each10094-2103a1b16f8-27a9-4085-9810-9b13ed0d420812018-12-13
10094-210-60EA - Each10094-2106b830fab-3fdc-4713-9ff6-97228d59d47912018-12-13

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 10 of 14 · 280 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lungex IIGINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b2024-10-28WarningsExact identifier
unii: 2968PHW8QP
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
ClobazamCLOBAZAMCamber Pharmaceuticals, Inc.cf31b8d1-0d19-4529-99b6-1f7366064a3c2024-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2MRO291B4U
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
ClobazamCLOBAZAMNorthStar RxLLC6f94e10e-ee4e-44e1-9c84-16c5d8c9b5942024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2MRO291B4U
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
ClobazamCLOBAZAMUpsher-Smith Laboratories, LLC6da2c381-057b-456a-b57b-464f8b3833712024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2MRO291B4U
CLOBAZAMCLOBAZAMNovadoz Pharmaceuticals LLCcf5bb37f-5386-47d3-8cec-d48253d359f62024-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2MRO291B4U
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
ClobazamCLOBAZAMAmneal Pharmaceuticals NY LLCa526ad73-d3c1-40b7-8e71-426b01cdea272024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2MRO291B4U
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSAmerican Regent, Inc.dc0462ee-4486-418c-865f-e2a71bdb8e9e2024-06-06Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ClobazamCLOBAZAMChartwell RX, LLC17c3b9db-9e25-4a17-ac45-bcd17ea0360c2024-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2MRO291B4U
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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