Home NDC 0187-1231 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-10-28 04:53 UTC 2022-10 N018677-001 CESAMET 1MG CAPSULE / ORAL RLD, RS 1985-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018677-001 CESAMET 1MG CAPSULE / ORAL RLD, RS 1985-12-26 e64feba35796…
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2N4O9L084N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 104885 Internal RxNorm lookup 311891 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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