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
Marketing end: 0000-00-00
Substance: NABILONE
Active strength: 1 mg/1
Pharmacologic classes: Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0187-1231		D	Discontinued by firm		2026-10-20
excluded package	package	0187-1231	0187-1231-50	D	Discontinued by firm		2026-10-20

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018677-001	CESAMET	NABILONE	1MG	CAPSULE / ORAL		RLD	1985-12-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b1c2261f-2e6e-2f98-ed99-aadd903b9620	Product name	1	20140508

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	Legacy NDC, 2 package rows	20220525_83c7ac15-ece9-47de-b83c-d575544fa449.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2N4O9L084N	NABILONE	51022-71-0	NABILONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
104885	Cesamet 1 MG Oral Capsule	PSN	83c7ac15-ece9-47de-b83c-d575544fa449	2
311891	nabilone 1 MG Oral Capsule	PSN	83c7ac15-ece9-47de-b83c-d575544fa449	2
104885	nabilone 1 MG Oral Capsule [Cesamet]	SBD	83c7ac15-ece9-47de-b83c-d575544fa449	2
311891	nabilone 1 MG Oral Capsule	SCD	83c7ac15-ece9-47de-b83c-d575544fa449	2
104885	Cesamet 1 MG Oral Capsule	SY	83c7ac15-ece9-47de-b83c-d575544fa449	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cesamet ® (nabilone) Capsules CII	Bausch Health US LLC \| Bausch Health Companies Inc.	2021-01-19	HUMAN PRESCRIPTION DRUG LABEL	2