FDA.reportPublic FDA data

Bromocriptine mesylate

Product NDC
65841-654
11-digit product format
658410654
Labeler code
65841
Product ID
65841-654_f9589272-83ad-497b-8a10-42ff73384d25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromocriptine mesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078899
Marketing category
ANDA
Marketing start
2009-01-23
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
65841-654-01Bromocriptine mesylate100 in 1 BOTTLECAPSULE10010
65841-654-06Bromocriptine mesylate30 in 1 BOTTLECAPSULE3010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMOCRIPTINE MESYLATEACTIVE INGREDIENTFFP983J3ODBROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
BROMOCRIPTINEACTIVE MOIETY3A64E3G5ZOBROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHBROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
GELATININACTIVE INGREDIENT2G86QN327LBROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
MALEIC ACIDINACTIVE INGREDIENT91XW058U2CBROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBROMOCRIPTINE MESYLATE CAPSULE [CADILA HEALTHCARE LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-654BROMOCRIPTINE MESYLATE CAPSULE [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 2 package rows20241128_97e7e051-ff64-4381-a869-6c1c364ad822.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197412bromocriptine mesylate 5 MG Oral CapsulePSN97e7e051-ff64-4381-a869-6c1c364ad82210
197412bromocriptine 5 MG Oral CapsuleSCD97e7e051-ff64-4381-a869-6c1c364ad82210
197412bromocriptine 5 MG (as bromocriptine mesylate 5.74 MG) Oral CapsuleSY97e7e051-ff64-4381-a869-6c1c364ad82210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-654-0165841065401100 CAPSULE in 1 BOTTLE (65841-654-01) 100 capsule2009-01-230000-00-00NoNoCurrent
65841-654-066584106540630 CAPSULE in 1 BOTTLE (65841-654-06) 30 capsule2009-01-230000-00-00NoNoCurrent