NDC 0187-1231

Cesamet

Nabilone

Cesamet is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Nabilone.

• Product ID: 0187-1231_83c7ac15-ece9-47de-b83c-d575544fa449
• NDC: 0187-1231
• Product Type: Human Prescription Drug
• Proprietary Name: Cesamet
• Generic Name: Nabilone
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2020-03-09
• Marketing Category: NDA / NDA
• Application Number: NDA018677
• Labeler Name: Bausch Health US LLC
• Substance Name: NABILONE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Cannabinoid [EPC],Cannabinoids [CS]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0187-1231-50

1 BOTTLE in 1 CARTON (0187-1231-50) > 50 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2020-03-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-1231-50 [00187123150]

Cesamet CAPSULE

• Marketing Category: NDA
• Application Number: NDA018677
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-09

Drug Details

Active Ingredients

Ingredient	Strength
NABILONE	1 mg/1

OpenFDA Data

• SPL SET ID: 83c7ac15-ece9-47de-b83c-d575544fa449
• Manufacturer:
  • Bausch Health US LLC
• 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