BROMOCRIPTINE MESYLATE

Product NDC
63304-158
11-digit product format
633040158
Labeler code
63304
Product ID
63304-158_cf0b0c2b-20a7-4142-8648-27bc3894cf73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromocriptine mesylate
Dosage form
CAPSULE
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
5 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
63304-158-01BROMOCRIPTINE MESYLATE100 in 1 BOTTLECAPSULE1004
63304-158-30BROMOCRIPTINE MESYLATE30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-158-01EA - Each63304-1588063952b-67f5-4ade-b53f-56dfbb0e81a312017-03-06
63304-158-30EA - Each63304-158a9315741-96e1-44c6-89b1-fb2daabab24b12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-158BROMOCRIPTINE 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
63304-158-0163304015801100 CAPSULE in 1 BOTTLE (63304-158-01) 100 capsule2016-12-220000-00-00NoNoCurrent
63304-158-306330401583030 CAPSULE in 1 BOTTLE (63304-158-30) 30 capsule2016-12-220000-00-00NoNoCurrent