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

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 Identifiers#

Field, Values table
FieldValues
UniiFFP983J3OD
Rxcui859077, 859081

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

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