cesamet

Generic: nabilone

Labeler: bausch health us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cesamet
Generic Name nabilone
Labeler bausch health us llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nabilone 1 mg/1

Manufacturer
Bausch Health US LLC

Identifiers & Regulatory

Product NDC 0187-1231
Product ID 0187-1231_c8ba6520-445a-4934-85f4-6f706cb21585
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018677
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-03-09

Pharmacologic Class

Established (EPC)
cannabinoid [epc]
Chemical Structure
cannabinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01871231
Hyphenated Format 0187-1231

Supplemental Identifiers

RxCUI
104885 311891
UNII
2N4O9L084N
NUI
N0000175782 M0003267

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 cesamet (source: ndc)
Generic Name nabilone (source: ndc)
Application Number NDA018677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0187-1231-50) / 50 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (1)

nabilone (1 mg/1)

Linked Drug Pages (1)

Cesamet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c8ba6520-445a-4934-85f4-6f706cb21585", "openfda": {"nui": ["N0000175782", "M0003267"], "unii": ["2N4O9L084N"], "rxcui": ["104885", "311891"], "spl_set_id": ["83c7ac15-ece9-47de-b83c-d575544fa449"], "pharm_class_cs": ["Cannabinoids [CS]"], "pharm_class_epc": ["Cannabinoid [EPC]"], "manufacturer_name": ["Bausch Health US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0187-1231-50)  / 50 CAPSULE in 1 BOTTLE", "package_ndc": "0187-1231-50", "marketing_start_date": "20200309"}], "brand_name": "Cesamet", "product_id": "0187-1231_c8ba6520-445a-4934-85f4-6f706cb21585", "dosage_form": "CAPSULE", "pharm_class": ["Cannabinoid [EPC]", "Cannabinoids [CS]"], "product_ndc": "0187-1231", "dea_schedule": "CII", "generic_name": "Nabilone", "labeler_name": "Bausch Health US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cesamet", "active_ingredients": [{"name": "NABILONE", "strength": "1 mg/1"}], "application_number": "NDA018677", "marketing_category": "NDA", "marketing_start_date": "20200309", "listing_expiration_date": "20261231"}