Prescription drug · NDA
Cesamet (Nabilone) NDC 0187-1231
Nabilone 1 mg/1 · Capsule · Oral · Bausch Health US LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Cesamet
- Generic name (nonproprietary)
- nabilone
- Active ingredients
- Nabilone — 1 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018677
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Cannabinoids (Chemical structure)
- Identifiers
- Product ID 0187-1231_c8ba6520-445a-4934-85f4-6f706cb21585SPL ID c8ba6520-445a-4934-85f4-6f706cb21585SPL set ID 83c7ac15-ece9-47de-b83c-d575544fa449RxCUI 104885, 311891UNII 2N4O9L084N
- Pharmacologic class
- Cannabinoid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents. Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments. Cesamet contai…
Excerpt only. Read the full label for complete information.
About NDC 0187-1231
- What is NDC 0187-1231?
- 0187-1231 is the product NDC for Cesamet (nabilone), Nabilone 1 mg/1 capsule, listed with the FDA by Bausch Health US LLC.
- What drug is associated with this NDC?
- Cesamet (Nabilone).
- What is the active ingredient?
- Nabilone.
- Who is the labeler?
- Bausch Health US LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cesamet?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.