FDA.reportPublic FDA data

Parlodel

Product NDC
30698-201
11-digit product format
306980201
Labeler code
30698
Product ID
30698-201_0bcbd9ce-2476-4426-bbbe-45828e72dc28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromocriptine mesylate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Validus Pharmaceuticals LLC
Application
NDA017962
Marketing category
NDA
Marketing start
2014-04-28
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
90f4f2b3-d032-9eaf-93c5-f165b5a4c90eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30698-201-012025-01-30C16284748780-1f386c649-f85f-0266-e053-dadaa90a7c1aParlodel Capsules and Tablets
30698-201-302025-01-30C16284748780-1f386c649-f85f-0266-e053-dadaa90a7c1aParlodel Capsules and Tablets
30698-201-012023-02-27C16284748780-1f386c649-f85f-0266-e053-dadaa90a7c1aParlodel Capsules and Tablets
30698-201-302023-02-27C16284748780-1f386c649-f85f-0266-e053-dadaa90a7c1aParlodel Capsules and Tablets
30698-201-012023-01-30C16284748780-1f386c649-f85f-0266-e053-dadaa90a7c1aParlodel Capsules and Tablets
30698-201-302023-01-30C16284748780-1f386c649-f85f-0266-e053-dadaa90a7c1aParlodel Capsules and Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-201-01Parlodel100 in 1 BOTTLECAPSULE, GELATIN COATED10011
30698-201-30Parlodel30 in 1 BOTTLECAPSULE, GELATIN COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-201-01EA - Each30698-20146af5736-8b27-40c4-9300-2d871fb4295d12017-03-06
30698-201-30EA - Each30698-201c29b2608-adc8-4e2d-af50-9b9d925da84912017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMOCRIPTINE MESYLATEACTIVE INGREDIENTFFP983J3ODPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
BROMOCRIPTINEACTIVE MOIETY3A64E3G5ZOPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
GELATININACTIVE INGREDIENT2G86QN327LPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
MALEIC ACIDINACTIVE INGREDIENT91XW058U2CPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-201PARLODEL (BROMOCRIPTINE MESYLATE) TABLET PARLODEL (BROMOCRIPTINE MESYLATE) CAPSULE, GELATIN COATED [VALIDUS PHARMACEUTICALS LLC]11Legacy NDC, 2 package rows20231215_fc2a08dd-4fb6-4ac4-9082-f99552fae25c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197411bromocriptine mesylate 2.5 MG Oral TabletPSNfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
197412bromocriptine mesylate 5 MG Oral CapsulePSNfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
105446Parlodel 2.5 MG Oral TabletPSNfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
105050Parlodel 5 MG Oral CapsulePSNfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
105446bromocriptine 2.5 MG Oral Tablet [Parlodel]SBDfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
105050bromocriptine 5 MG Oral Capsule [Parlodel]SBDfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
197411bromocriptine 2.5 MG Oral TabletSCDfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
197412bromocriptine 5 MG Oral CapsuleSCDfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSYfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
197412bromocriptine 5 MG (as bromocriptine mesylate 5.74 MG) Oral CapsuleSYfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
105446Parlodel 2.5 MG Oral TabletSYfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
105050Parlodel 5 MG Oral CapsuleSYfc2a08dd-4fb6-4ac4-9082-f99552fae25c11
105446Parlodel SnapTabs 2.5 MG Oral TabletSYfc2a08dd-4fb6-4ac4-9082-f99552fae25c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
30698-201-0130698020101100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-201-01) 2014-04-280000-00-00NoNoCurrent
30698-201-303069802013030 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-201-30) 2014-04-280000-00-00NoNoCurrent