Bromocriptine Mesylate

Product NDC
0378-7096
11-digit product format
003787096
Labeler code
0378
Product ID
0378-7096_caaa8c54-ee5c-47a9-8455-1f49fab45143
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromocriptine mesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077226
Marketing category
ANDA
Marketing start
2013-06-17
Substance
BROMOCRIPTINE MESYLATE
Active strength
5 mg/1
Pharmacologic classes
Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bromocriptine Mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMOCRIPTINE MESYLATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFFP983J3OD
Rxcui197412

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
0378-7096-01Bromocriptine Mesylate100 in 1 BOTTLE, UNIT-DOSECAPSULE10011
0378-7096-93Bromocriptine Mesylate30 in 1 BOTTLE, UNIT-DOSECAPSULE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7096-01EA - Each0378-7096284332f1-9b8f-4244-919c-32133a4d427a12012-07-24
0378-7096-93EA - Each0378-7096a2d83ec8-8a80-4fa0-b9b5-7f92de87ad9212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMOCRIPTINE MESYLATEACTIVE INGREDIENTFFP983J3ODBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
BROMOCRIPTINEACTIVE MOIETY3A64E3G5ZOBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3BROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
GELATININACTIVE INGREDIENT2G86QN327LBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
MALEIC ACIDINACTIVE INGREDIENT91XW058U2CBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7096BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20211117_72d8eefe-c066-41b6-8922-9586f1cf47a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197412bromocriptine mesylate 5 MG Oral CapsulePSN72d8eefe-c066-41b6-8922-9586f1cf47a111
197412bromocriptine 5 MG Oral CapsuleSCD72d8eefe-c066-41b6-8922-9586f1cf47a111
197412bromocriptine 5 MG (as bromocriptine mesylate 5.74 MG) Oral CapsuleSY72d8eefe-c066-41b6-8922-9586f1cf47a111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7096-0100378709601100 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-01) 100 capsule2013-07-010000-00-00NoNoCurrent
0378-7096-930037870969330 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-93) 30 capsule2013-06-170000-00-00NoNoCurrent