CYCLOSET

Product NDC
73515-123
11-digit product format
735150123
Labeler code
73515
Product ID
73515-123_d584b098-e98a-4453-aa48-9d79a470036c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromocriptine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Avvisto Therapeutics LLC
Application
NDA020866
Marketing category
NDA
Marketing start
2024-05-23
Substance
BROMOCRIPTINE MESYLATE
Active strength
.8 mg/1
Pharmacologic classes
Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020866-001CYCLOSETBROMOCRIPTINE MESYLATEEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05

Orange Book patents#

Current patent rows page 1 of 2 · 126 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N020866-001106881552030-06-07U-22812020-08-18
N020866-001106881552030-06-07U-28902020-08-18
N020866-001106881552030-06-07U-28912020-08-18
N020866-001106881552030-06-07U-28922020-08-18
N020866-001106881552030-06-07U-28932020-08-18
N020866-001106881552030-06-07U-28942020-08-18
N020866-001106881552030-06-07U-28952020-08-18
N020866-001106881552030-06-07U-28962020-08-18
N020866-001106881552030-06-07U-28972020-08-18
N020866-001106881552030-06-07U-28982020-08-18
N020866-001106881552030-06-07U-28992020-08-18
N020866-001106881552030-06-07U-29002020-08-18
N020866-001106881552030-06-07U-29012020-08-18
N020866-001106881552030-06-07U-29022020-08-18
N020866-001106881552030-06-07U-29032020-08-18
N020866-001106881552030-06-07U-29042020-08-18
N020866-001106881552030-06-07U-29052020-08-18
N020866-001106881552030-06-07U-29062020-08-18
N020866-001106881552030-06-07U-29072020-08-18
N020866-001106881552030-06-07U-29082020-08-18
N020866-001106881552030-06-07U-29092020-08-18
N020866-001106881552030-06-07U-29102020-08-18
N020866-001106881552030-06-07U-29112020-08-18
N020866-001106881552030-06-07U-29122020-08-18
N020866-001106881552030-06-07U-29132020-08-18
N020866-001106881552030-06-07U-29142020-08-18
N020866-001106881552030-06-07U-29152020-08-18
N020866-001106881552030-06-07U-29162020-08-18
N020866-001106881552030-06-07U-29172020-08-18
N020866-001106881552030-06-07U-29182020-08-18
N020866-001106881552030-06-07U-29192020-08-18
N020866-001106881552030-06-07U-29202020-08-18
N020866-001106881552030-06-07U-29212020-08-18
N020866-001106881552030-06-07U-29222020-08-18
N020866-001106881552030-06-07U-29232020-08-18
N020866-001106881552030-06-07U-29242020-08-18
N020866-001106881552030-06-07U-29252020-08-18
N020866-001106881552030-06-07U-29262020-08-18
N020866-001106881552030-06-07U-29272020-08-18
N020866-001106881552030-06-07U-29282020-08-18
N020866-001106881552030-06-07U-29292020-08-18
N020866-001106881552030-06-07U-29302020-08-18
N020866-001106881552030-06-07U-29312020-08-18
N020866-001106881552030-06-07U-29322020-08-18
N020866-001106881552030-06-07U-29332020-08-18
N020866-001106881552030-06-07U-29342020-08-18
N020866-001106881552030-06-07U-29352020-08-18
N020866-001106881552030-06-07U-29362020-08-18
N020866-001106881552030-06-07U-29372020-08-18
N020866-00188777082030-06-07U-1706Drug product2015-06-18
N020866-00193520252030-06-07U-21112017-09-27
N020866-00193520252030-06-07U-21122017-09-27
N020866-00193520252030-06-07U-21132017-09-27
N020866-00193520252030-06-07U-21142017-09-27
N020866-00193520252030-06-07U-21152017-09-27
N020866-00193520252030-06-07U-21162017-09-27
N020866-00193520252030-06-07U-21172017-09-27
N020866-00193520252030-06-07U-21182017-09-27
N020866-00193520252030-06-07U-21192017-09-27
N020866-00198954222030-06-07U-21142018-05-07
N020866-00198954222030-06-07U-21162018-05-07
N020866-00198954222030-06-07U-22812018-05-07
N020866-00198954222030-06-07U-22822018-05-07
N020866-00198954222030-06-07U-22832018-05-07
N020866-00198954222030-06-07U-22842018-05-07
N020866-00198954222030-06-07U-22852018-05-07
N020866-00198954222030-06-07U-22862018-05-07
N020866-00198954222030-06-07U-22872018-05-07
N020866-001106880942032-04-30U-28702020-08-11
N020866-001106880942032-04-30U-28712020-08-11
N020866-001106880942032-04-30U-28722020-08-11
N020866-001106880942032-04-30U-28732020-08-11
N020866-001106880942032-04-30U-28742020-08-11
N020866-001106880942032-04-30U-28752020-08-11
N020866-001106880942032-04-30U-28762020-08-11
N020866-001106880942032-04-30U-28772020-08-11
N020866-001106880942032-04-30U-28782020-08-11
N020866-001106880942032-04-30U-28792020-08-11
N020866-001106880942032-04-30U-28802020-08-11
N020866-001106880942032-04-30U-28812020-08-11

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-053f01610625f2…
2019-09-15 20:21 UTC2019-09N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020866-001CYCLOSETEQ 0.8MG BASETABLET / ORALRLD, RS2009-05-05cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 121 · 4,830 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28982020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29052020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29022020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28902020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29142020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29112020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29032020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-22812020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29012020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29122020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28912020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28962020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28932020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28992020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29042020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29002020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29062020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29082020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29132020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28942020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29102020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28922020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28952020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29092020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-28972020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29072020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29362020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29152020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29352020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29322020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29242020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29262020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29312020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29272020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29182020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29332020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29162020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29202020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29222020-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020866-001106881552030-06-07U-29212020-08-18011fe1cb6892…

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOSET
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMOCRIPTINE MESYLATE.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FFP983J3ODInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859077Internal RxNorm lookup
859081Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42ba916-16b9-4d1c-8d09-9d2fbb1b6c20Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
90f4f2b3-d032-9eaf-93c5-f165b5a4c90eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73515-123-21CYCLOSET21 in 1 BOTTLETABLET217
73515-123-30CYCLOSET200 in 1 BOTTLETABLET2007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73515-123-30EA - Each73515-12325abe12e-318b-4ed1-9fa4-2fa57635a67912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73515-123CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [AVVISTO THERAPEUTICS LLC]6Current NDC, 2 package rows20241027_e42ba916-16b9-4d1c-8d09-9d2fbb1b6c20.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOSETBROMOCRIPTINE MESYLATEAvvisto Therapeutics LLCe42ba916-16b9-4d1c-8d09-9d2fbb1b6c202026-01-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 020866
application number: NDA020866
ndc (product): 73515-123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859077bromocriptine mesylate 0.8 MG Oral TabletPSNe42ba916-16b9-4d1c-8d09-9d2fbb1b6c207
859081CYCLOSET 0.8 MG Oral TabletPSNe42ba916-16b9-4d1c-8d09-9d2fbb1b6c207
859081bromocriptine 0.8 MG Oral Tablet [Cycloset]SBDe42ba916-16b9-4d1c-8d09-9d2fbb1b6c207
859077bromocriptine 0.8 MG Oral TabletSCDe42ba916-16b9-4d1c-8d09-9d2fbb1b6c207
859081Cycloset 0.8 MG Oral TabletSYe42ba916-16b9-4d1c-8d09-9d2fbb1b6c207

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73515-123-217351501232121 TABLET in 1 BOTTLE (73515-123-21) 21 tablet2024-05-23NoNoCurrent
73515-123-3073515012330200 TABLET in 1 BOTTLE (73515-123-30) 200 tablet2024-05-23NoNoCurrent