Home NDC 68012-258-21 CYCLOSET
Product NDC 68012-258
Requested package NDC 68012-258-21
11-digit product format 680120258
Labeler code 68012
Product ID 68012-258_24cac959-31c4-4313-8824-5fff07d343ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bromocriptine mesylate
Dosage form TABLET
Route ORAL
Labeler Santarus, Inc.
Application NDA020866
Marketing category NDA
Marketing start 2010-11-15
Marketing end 0000-00-00
Substance BROMOCRIPTINE MESYLATE
Active strength 1 mg/1
Pharmacologic classes Ergot Derivative [EPC],Ergolines [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68012-258 68012-258-21 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68012-258 68012-258-21 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020866-001 CYCLOSET BROMOCRIPTINE MESYLATE EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05
Orange Book patents# Current patent rows page 1 of 2 · 126 matching rows.
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020866-001 CYCLOSET EQ 0.8MG BASE TABLET / ORAL RLD, RS 2009-05-05 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 121 · 4,830 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded bromocriptine mesylate ACTIVE INGREDIENT FFP983J3OD CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.] 4 bromocriptine ACTIVE MOIETY 3A64E3G5ZO CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.] 4 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.] 4 lactose INACTIVE INGREDIENT J2B2A4N98G CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.] 4 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.] 4 starch, corn INACTIVE INGREDIENT O8232NY3SJ CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68012-258 CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.] 18 Legacy NDC 20250131_3e719d6a-342e-428b-93d3-377d31cb15c7.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CYCLOSET BROMOCRIPTINE MESYLATE Avvisto Therapeutics LLC e42ba916-16b9-4d1c-8d09-9d2fbb1b6c20 2026-01-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 020866 application number: NDA020866
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68012-258-21 68012025821 21 TABLET in 1 BOTTLE (68012-258-21) 21 tablet 2010-11-15 0000-00-00 No No Current