Bromocriptine mesylate

Product NDC
68382-110
11-digit product format
683820110
Labeler code
68382
Product ID
68382-110_b9165827-6509-4d3c-813a-547929b720da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromocriptine mesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
68382-110-01Bromocriptine mesylate100 in 1 BOTTLECAPSULE10013
68382-110-06Bromocriptine mesylate30 in 1 BOTTLECAPSULE3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-110BROMOCRIPTINE MESYLATE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20230917_d69003ee-0b6f-47a9-834e-ba59c02f566c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197412bromocriptine mesylate 5 MG Oral CapsulePSNd69003ee-0b6f-47a9-834e-ba59c02f566c13
197412bromocriptine 5 MG Oral CapsuleSCDd69003ee-0b6f-47a9-834e-ba59c02f566c13
197412bromocriptine 5 MG (as bromocriptine mesylate 5.74 MG) Oral CapsuleSYd69003ee-0b6f-47a9-834e-ba59c02f566c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-110-0168382011001100 CAPSULE in 1 BOTTLE (68382-110-01) 100 capsule2009-01-230000-00-00NoNoCurrent
68382-110-066838201100630 CAPSULE in 1 BOTTLE (68382-110-06) 30 capsule2009-01-230000-00-00NoNoCurrent