FDA.reportPublic FDA data

Bromocriptine mesylate

Product NDC
0574-0106
11-digit product format
005740106
Labeler code
0574
Product ID
0574-0106_3a655bc4-d44e-4dd2-a951-211d8484f788
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromocriptine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Padagis US LLC
Application
ANDA077646
Marketing category
ANDA
Marketing start
2014-04-01
Substance
BROMOCRIPTINE MESYLATE
Active strength
2.5 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 MESYLATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFFP983J3OD
Rxcui197411

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
0574-0106-01Bromocriptine mesylate100 in 1 BOTTLE, PLASTICTABLET10010
0574-0106-03Bromocriptine mesylate30 in 1 BOTTLE, PLASTICTABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0106-01EA - Each0574-01061fcfd8c6-da7b-4774-9f7e-e28967fdc7cc12012-07-24
0574-0106-03EA - Each0574-0106c0670a8f-fd1a-43eb-9aa5-2afbb539a4d012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMOCRIPTINE MESYLATEACTIVE INGREDIENTFFP983J3ODBROMOCRIPTINE MESYLATE TABLET [CARILION MATERIALS MANAGEMENT]2
BROMOCRIPTINEACTIVE MOIETY3A64E3G5ZOBROMOCRIPTINE MESYLATE TABLET [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBROMOCRIPTINE MESYLATE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BROMOCRIPTINE MESYLATE TABLET [CARILION MATERIALS MANAGEMENT]2
MALEIC ACIDINACTIVE INGREDIENT91XW058U2CBROMOCRIPTINE MESYLATE TABLET [CARILION MATERIALS MANAGEMENT]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35BROMOCRIPTINE MESYLATE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BROMOCRIPTINE MESYLATE TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBROMOCRIPTINE MESYLATE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-0106BROMOCRIPTINE MESYLATE TABLET [PADAGIS US LLC]10Current NDC, Legacy NDC, 2 package rows20241123_0ee2da00-faf8-4c51-a696-9462fa4f6050.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197411bromocriptine mesylate 2.5 MG Oral TabletPSN0ee2da00-faf8-4c51-a696-9462fa4f605010
197411bromocriptine 2.5 MG Oral TabletSCD0ee2da00-faf8-4c51-a696-9462fa4f605010
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSY0ee2da00-faf8-4c51-a696-9462fa4f605010
197411bromocriptine mesylate 2.5 MG Oral TabletPSNb89ff149-e33a-46cb-9649-64583e78a7ee4
197411bromocriptine 2.5 MG Oral TabletSCDb89ff149-e33a-46cb-9649-64583e78a7ee4
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSYb89ff149-e33a-46cb-9649-64583e78a7ee4
197411bromocriptine mesylate 2.5 MG Oral TabletPSN29827cb6-f8fe-424f-80ef-48f4ef4601221
197411bromocriptine 2.5 MG Oral TabletSCD29827cb6-f8fe-424f-80ef-48f4ef4601221
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSY29827cb6-f8fe-424f-80ef-48f4ef4601221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-0106-0100574010601100 TABLET in 1 BOTTLE, PLASTIC (0574-0106-01) 100 tablet2014-04-010000-00-00NoNoCurrent
0574-0106-030057401060330 TABLET in 1 BOTTLE, PLASTIC (0574-0106-03) 30 tablet2014-04-010000-00-00NoNoCurrent