Cesamet
- Product NDC
- 0187-1231
- 11-digit product format
- 001871231
- Labeler code
- 0187
- Product ID
- 0187-1231_c8ba6520-445a-4934-85f4-6f706cb21585
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nabilone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bausch Health US LLC
- Application
- NDA018677
- Marketing category
- NDA
- Marketing start
- 2020-03-09
- Substance
- NABILONE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Cannabinoid [EPC], Cannabinoids [CS]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cesamet
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NABILONE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2N4O9L084N |
| Rxcui | 104885, 311891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0187-1231-50 | Cesamet | 1 in 1 CARTON | CAPSULE | 1 | | 2 |
| 0187-1231-50 | Cesamet | 50 in 1 BOTTLE | CAPSULE | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-1231 | CESAMET (NABILONE) CAPSULE [BAUSCH HEALTH US LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220525_83c7ac15-ece9-47de-b83c-d575544fa449.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0187-1231-50 | 00187123150 | 1 BOTTLE in 1 CARTON (0187-1231-50) / 50 CAPSULE in 1 BOTTLE | 1 bottle | 2020-03-09 | 0000-00-00 | No | No | Current |