NDC 10094-205

SYMPAZAN

Clobazam

SYMPAZAN is a Oral Film in the Human Prescription Drug category. It is labeled and distributed by Aquestive Therapeutics. The primary component is Clobazam.

• Product ID: 10094-205_28a44a54-1fa1-4933-aecc-5adcc5df8ca7
• NDC: 10094-205
• Product Type: Human Prescription Drug
• Proprietary Name: SYMPAZAN
• Generic Name: Clobazam
• Dosage Form: Film
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA210833
• Labeler Name: Aquestive Therapeutics
• Substance Name: CLOBAZAM
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 10094-205-60

60 POUCH in 1 PACKAGE (10094-205-60) > 1 FILM in 1 POUCH (10094-205-01)

• Marketing Start Date: 2018-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10094-205-60 [10094020560]

SYMPAZAN FILM

• Marketing Category: NDA
• Application Number: NDA210833
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-01

NDC 10094-205-01 [10094020501]

SYMPAZAN FILM

• Marketing Category: NDA
• Application Number: NDA210833
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-01

Drug Details

Active Ingredients

Ingredient	Strength
CLOBAZAM	5 mg/1

OpenFDA Data

• SPL SET ID: 5e3d8fcb-aa7d-4822-88fc-4f06264c3242
• Manufacturer:
  • Aquestive Therapeutics
• UNII:
  • 2MRO291B4U
• RxNorm Concept Unique ID - RxCUI:
  • 2102715
  • 2102717
  • 2102713
  • 2058253
  • 2058255
  • 2058254

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Cytochrome P450 3A4 Inducers [MoA]

NDC Crossover Matching brand name "SYMPAZAN" or generic name "Clobazam"

NDC	Brand Name	Generic Name
10094-205	SYMPAZAN	clobazam
10094-210	SYMPAZAN	clobazam
10094-220	SYMPAZAN	clobazam
0054-0526	Clobazam	Clobazam
0054-0527	Clobazam	Clobazam
0054-0561	clobazam	clobazam
0378-8043	Clobazam	Clobazam
0527-1681	Clobazam	clobazam
0527-1682	Clobazam	clobazam
0527-5301	Clobazam	clobazam
0781-8013	Clobazam	Clobazam
0781-8014	Clobazam	Clobazam
0832-0580	Clobazam	Clobazam
0832-0581	Clobazam	Clobazam
0832-0585	Clobazam	clobazam