CYCLOSET

Product NDC
68012-258
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68012-258-20EA - Each68012-258b80615cf-d9e3-4843-904b-cca0832284c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bromocriptine mesylateACTIVE INGREDIENTFFP983J3ODCYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.]4
bromocriptineACTIVE MOIETY3A64E3G5ZOCYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.]4
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.]4
lactoseINACTIVE INGREDIENTJ2B2A4N98GCYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.]4
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.]4
starch, cornINACTIVE INGREDIENTO8232NY3SJCYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68012-258CYCLOSET (BROMOCRIPTINE MESYLATE) TABLET [SANTARUS, INC.]18Legacy NDC20250131_3e719d6a-342e-428b-93d3-377d31cb15c7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68012-258-2068012025820200 TABLET in 1 BOTTLE (68012-258-20) 200 tablet2010-11-150000-00-00NoNoCurrent
68012-258-216801202582121 TABLET in 1 BOTTLE (68012-258-21) 21 tablet2010-11-150000-00-00NoNoCurrent