sympazan

Generic: clobazam

Labeler: aquestive therapeutics
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sympazan
Generic Name clobazam
Labeler aquestive therapeutics
Dosage Form FILM
Routes
ORAL
Active Ingredients

clobazam 10 mg/1

Manufacturer
Aquestive Therapeutics

Identifiers & Regulatory

Product NDC 10094-210
Product ID 10094-210_4a004ed9-140a-4054-843c-4e31d42667ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210833
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-11-01

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Mechanism of Action
cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inducers [moa]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10094210
Hyphenated Format 10094-210

Supplemental Identifiers

RxCUI
2058253 2058254 2058255 2102713 2102715 2102717
UNII
2MRO291B4U
NUI
N0000175694 M0002356 N0000182137 N0000185506

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sympazan (source: ndc)
Generic Name clobazam (source: ndc)
Application Number NDA210833 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 60 POUCH in 1 PACKAGE (10094-210-60) / 1 FILM in 1 POUCH (10094-210-01)
source: ndc

Packages (1)

10094-210-60 60 POUCH in 1 PACKAGE (10094-210-60) / 1 FILM in 1 POUCH (10094-210-01)

Ingredients (1)

clobazam (10 mg/1)

Linked Drug Pages (1)

SYMPAZAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a004ed9-140a-4054-843c-4e31d42667ec", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "unii": ["2MRO291B4U"], "rxcui": ["2058253", "2058254", "2058255", "2102713", "2102715", "2102717"], "spl_set_id": ["5e3d8fcb-aa7d-4822-88fc-4f06264c3242"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "pharm_class_moa": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "manufacturer_name": ["Aquestive Therapeutics"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 POUCH in 1 PACKAGE (10094-210-60)  / 1 FILM in 1 POUCH (10094-210-01)", "package_ndc": "10094-210-60", "marketing_start_date": "20181101"}], "brand_name": "SYMPAZAN", "product_id": "10094-210_4a004ed9-140a-4054-843c-4e31d42667ec", "dosage_form": "FILM", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "10094-210", "dea_schedule": "CIV", "generic_name": "clobazam", "labeler_name": "Aquestive Therapeutics", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SYMPAZAN", "active_ingredients": [{"name": "CLOBAZAM", "strength": "10 mg/1"}], "application_number": "NDA210833", "marketing_category": "NDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}