BROMOCRIPTINE MESYLATE

Product NDC
63304-962
11-digit product format
633040962
Labeler code
63304
Product ID
63304-962_cf0b0c2b-20a7-4142-8648-27bc3894cf73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromocriptine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA017962
Marketing category
NDA
Marketing start
2016-12-22
Marketing end
0000-00-00
Substance
BROMOCRIPTINE MESYLATE
Active strength
3 mg/1
Pharmacologic classes
Ergot Derivative [EPC],Ergolines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
90f4f2b3-d032-9eaf-93c5-f165b5a4c90eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-962-01BROMOCRIPTINE MESYLATE100 in 1 BOTTLETABLET1004
63304-962-30BROMOCRIPTINE MESYLATE30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-962-01EA - Each63304-962cdf797ac-8b79-4c1d-844b-005d7f09dbec12017-03-06
63304-962-30EA - Each63304-962137ae8c4-d720-4bbe-85f8-15296741ada012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-962BROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Legacy NDC, 2 package rows20200212_44cc1e5f-c509-40e6-ac51-eba6d0440b16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197411bromocriptine mesylate 2.5 MG Oral TabletPSN44cc1e5f-c509-40e6-ac51-eba6d0440b164
197412bromocriptine mesylate 5 MG Oral CapsulePSN44cc1e5f-c509-40e6-ac51-eba6d0440b164
197411bromocriptine 2.5 MG Oral TabletSCD44cc1e5f-c509-40e6-ac51-eba6d0440b164
197412bromocriptine 5 MG Oral CapsuleSCD44cc1e5f-c509-40e6-ac51-eba6d0440b164
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSY44cc1e5f-c509-40e6-ac51-eba6d0440b164
197412bromocriptine 5 MG (as bromocriptine mesylate 5.74 MG) Oral CapsuleSY44cc1e5f-c509-40e6-ac51-eba6d0440b164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-962-0163304096201100 TABLET in 1 BOTTLE (63304-962-01) 100 tablet2016-12-220000-00-00NoNoCurrent
63304-962-306330409623030 TABLET in 1 BOTTLE (63304-962-30) 30 tablet2016-12-220000-00-00NoNoCurrent