NDC 0037-1221

Cesamet

Nabilone

Cesamet is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Nabilone.

• Product ID: 0037-1221_4c7ace1c-2f7e-442e-9852-1a8c5f802109
• NDC: 0037-1221
• Product Type: Human Prescription Drug
• Proprietary Name: Cesamet
• Generic Name: Nabilone
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2010-03-01
• Marketing End Date: 2020-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA018677
• Labeler Name: Meda Pharmaceuticals
• Substance Name: NABILONE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Cannabinoid [EPC],Cannabinoids [CS]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 0037-1221-50

1 BOTTLE in 1 CARTON (0037-1221-50) > 50 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2010-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-1221-50 [00037122150]

Cesamet CAPSULE

• Marketing Category: NDA
• Application Number: NDA018677
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-03-01
• Marketing End Date: 2020-03-31

Drug Details

Active Ingredients

Ingredient	Strength
NABILONE	1 mg/1

OpenFDA Data

• SPL SET ID: bb582d64-0f51-11df-8a39-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals Inc.
• UNII:
  • 2N4O9L084N
• RxNorm Concept Unique ID - RxCUI:
  • 104885
  • 311891

Pharmacological Class

• Cannabinoid [EPC]
• Cannabinoids [CS]

NDC Crossover Matching brand name "Cesamet" or generic name "Nabilone"

NDC	Brand Name	Generic Name
0037-1221	Cesamet	Nabilone
0187-1231	Cesamet	Nabilone