FDA.reportPublic FDA data

SYMPAZAN

Product NDC
10094-220
11-digit product format
100940220
Labeler code
10094
Product ID
10094-220_4a004ed9-140a-4054-843c-4e31d42667ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobazam
Dosage form
FILM
Route
ORAL
Labeler
Aquestive Therapeutics
Application
NDA210833
Marketing category
NDA
Marketing start
2018-11-01
Substance
CLOBAZAM
Active strength
20 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBAZAM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2MRO291B4U
Rxcui2058253, 2058254, 2058255, 2102713, 2102715, 2102717

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
713032fb-f461-4501-be8a-ca575cddec45Product name720211028
f324c243-b420-476a-968a-bb1445dcc148Product name120190211
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10094-220-01SYMPAZAN1 in 1 POUCHFILM114
10094-220-60SYMPAZAN60 in 1 PACKAGEFILM6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10094-220-01EA - Each10094-22039caeef7-696a-4315-aa05-c29583c67fb112018-12-13
10094-220-60EA - Each10094-2201a529447-8f25-49bf-9d63-c8176affaa8e12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10094-220SYMPAZAN (CLOBAZAM) FILM [AQUESTIVE THERAPEUTICS]12Current NDC, Legacy NDC, 2 package rows20240316_5e3d8fcb-aa7d-4822-88fc-4f06264c3242.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2058253cloBAZam 10 MG Oral FilmPSN5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2058254cloBAZam 20 MG Oral FilmPSN5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2058255cloBAZam 5 MG Oral FilmPSN5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102713Sympazan 10 MG Oral FilmPSN5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102715Sympazan 20 MG Oral FilmPSN5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102717Sympazan 5 MG Oral FilmPSN5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102713clobazam 10 MG Oral Film [Sympazan]SBD5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102715clobazam 20 MG Oral Film [Sympazan]SBD5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102717clobazam 5 MG Oral Film [Sympazan]SBD5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2058253clobazam 10 MG Oral FilmSCD5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2058254clobazam 20 MG Oral FilmSCD5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2058255clobazam 5 MG Oral FilmSCD5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102713Sympazan 10 MG Oral FilmSY5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102715Sympazan 20 MG Oral FilmSY5e3d8fcb-aa7d-4822-88fc-4f06264c324214
2102717Sympazan 5 MG Oral FilmSY5e3d8fcb-aa7d-4822-88fc-4f06264c324214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10094-220-01100940220011 in 1 POUCHHistorical
10094-220-601009402206060 POUCH in 1 PACKAGE (10094-220-60) / 1 FILM in 1 POUCH (10094-220-01) 60 pouch2018-11-010000-00-00NoNoCurrent