NDC 67386-313

Onfi

Clobazam

Onfi is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Lundbeck Pharmaceuticals Llc. The primary component is Clobazam.

• Product ID: 67386-313_058376fd-0ee9-4e10-92aa-02d3a1692675
• NDC: 67386-313
• Product Type: Human Prescription Drug
• Proprietary Name: Onfi
• Generic Name: Clobazam
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2012-12-14
• Marketing Category: NDA / NDA
• Application Number: NDA203993
• Labeler Name: Lundbeck Pharmaceuticals LLC
• Substance Name: CLOBAZAM
• Active Ingredient Strength: 3 mg/mL
• 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 67386-313-21

1 BOTTLE in 1 CARTON (67386-313-21) > 120 mL in 1 BOTTLE

• Marketing Start Date: 2012-12-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67386-313-21 [67386031321]

Onfi SUSPENSION

• Marketing Category: NDA
• Application Number: NDA203993
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-12-14

Drug Details

Active Ingredients

Ingredient	Strength
CLOBAZAM	2.5 mg/mL

OpenFDA Data

• SPL SET ID: de03bd69-2dca-459c-93b4-541fd3e9571c
• Manufacturer:
  • Lundbeck Pharmaceuticals LLC
• UNII:
  • 2MRO291B4U
• RxNorm Concept Unique ID - RxCUI:
  • 1191058
  • 246172
  • 1191056
  • 1366196
  • 1366192
  • 199450
• UPC Code:
  • 0367386313217

Pharmacological Class

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

Medicade Reported Pricing

67386031321 ONFI 2.5 MG/ML SUSPENSION

Pricing Unit: ML | Drug Type:

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

NDC	Brand Name	Generic Name
67386-313	Onfi	Onfi
67386-314	Onfi	Onfi
67386-315	Onfi	Onfi
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
10094-205	SYMPAZAN	clobazam
10094-210	SYMPAZAN	clobazam
10094-220	SYMPAZAN	clobazam