CYCLOSET
These highlights do not include all the information needed to use CYCLOSET safely and effectively. See full prescribing information for CYCLOSET. CYCLOSET (bromocriptine mesylate tablets), for oral use Initial U.S. Approval: 1978
Approved
Approval ID
3e719d6a-342e-428b-93d3-377d31cb15c7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2020
Manufacturers
FDA
Santarus, Inc.
DUNS: 104286369
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bromocriptine mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68012-258
Application NumberNDA020866
Product Classification
M
Marketing Category
C73594
G
Generic Name
bromocriptine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (6)
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
bromocriptine mesylateActive
Quantity: 0.8 mg in 1 1
Code: FFP983J3OD
Classification: ACTIM
lactose, unspecified formInactive
Code: J2B2A4N98G
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT