Bromocriptine mesylate

Product NDC
0781-5325
11-digit product format
007815325
Labeler code
0781
Product ID
0781-5325_9767701b-743a-406f-8c25-d97a6ef29aa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromocriptine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA074631
Marketing category
ANDA
Marketing start
1998-01-13
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
0781-5325-01Bromocriptine mesylate100 in 1 BOTTLETABLET10010
0781-5325-31Bromocriptine mesylate30 in 1 BOTTLETABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5325-01EA - Each0781-5325844a884d-db2c-4c7a-aff7-2428503a5c0712013-02-13
0781-5325-31EA - Each0781-5325d78fc06d-3b82-485e-b50f-46e6908055fd12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMOCRIPTINE MESYLATEACTIVE INGREDIENTFFP983J3ODBROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5
BROMOCRIPTINEACTIVE MOIETY3A64E3G5ZOBROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5
MALEIC ACIDINACTIVE INGREDIENT91XW058U2CBROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EBROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5325BROMOCRIPTINE MESYLATE TABLET [SANDOZ INC]10Current NDC, Legacy NDC, 2 package rows20241024_c43c300d-8aec-4020-984a-42c1a917c08f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197411bromocriptine mesylate 2.5 MG Oral TabletPSNc43c300d-8aec-4020-984a-42c1a917c08f10
197411bromocriptine 2.5 MG Oral TabletSCDc43c300d-8aec-4020-984a-42c1a917c08f10
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSYc43c300d-8aec-4020-984a-42c1a917c08f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5325-0100781532501100 TABLET in 1 BOTTLE (0781-5325-01) 100 tablet1998-01-130000-00-00NoNoCurrent
0781-5325-310078153253130 TABLET in 1 BOTTLE (0781-5325-31) 30 tablet1998-01-130000-00-00NoNoCurrent