FDA.reportPublic FDA data

Intrarosa

Product NDC
64011-601
11-digit product format
640110601
Labeler code
64011
Product ID
64011-601_9bf80c3a-bb4a-4a90-8729-b2920ec3f620
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prasterone
Dosage form
INSERT
Route
VAGINAL
Labeler
AMAG Pharmaceuticals, Inc.
Application
NDA208470
Marketing category
NDA
Marketing start
2017-07-24
Marketing end
0000-00-00
Substance
PRASTERONE
Active strength
7 mg/1
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
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64011-601-142022-01-28C16284748780-1d6a99b39-b39b-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use INTRAROSA ® safely and effectively. See full prescribing information for INTRAROSA ® . INTRAROSA ® (prasterone) vaginal inserts Initial U.S. Approval: 2016
64011-601-282022-01-28C16284748780-1d6a99b39-b39b-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use INTRAROSA ® safely and effectively. See full prescribing information for INTRAROSA ® . INTRAROSA ® (prasterone) vaginal inserts Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64011-601-14Intrarosa14 in 1 BOXINSERT148
64011-601-14Intrarosa1 in 1 BOXINSERT18
64011-601-28Intrarosa28 in 1 BOXINSERT288
64011-601-28Intrarosa1 in 1 BOXINSERT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64011-601-28EA - Each64011-6015d87c3c0-b2ed-4844-831f-a343f0a0610212017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64011-601INTRAROSA (PRASTERONE) INSERT [AMAG PHARMACEUTICALS, INC.]8Legacy NDC, 4 package rows20201112_df731acd-7276-4fef-b037-bc7f30c112cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1927693Intrarosa 6.5 MG Vaginal InsertPSNdf731acd-7276-4fef-b037-bc7f30c112cb8
1927688prasterone 6.5 MG Vaginal InsertPSNdf731acd-7276-4fef-b037-bc7f30c112cb8
1927693prasterone 6.5 MG Vaginal Insert [Intrarosa]SBDdf731acd-7276-4fef-b037-bc7f30c112cb8
1927688prasterone 6.5 MG Vaginal InsertSCDdf731acd-7276-4fef-b037-bc7f30c112cb8
1927688dehydroepiandrosterone (prasterone) 6.5 MG Vaginal InsertSYdf731acd-7276-4fef-b037-bc7f30c112cb8
1927693Intrarosa (prasterone) 6.5 MG Vaginal InsertSYdf731acd-7276-4fef-b037-bc7f30c112cb8
1927693Intrarosa 6.5 MG Vaginal InsertSYdf731acd-7276-4fef-b037-bc7f30c112cb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64011-601-14640110601141 BOX in 1 BOX (64011-601-14) > 14 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK1 box2017-07-240000-00-00NoNoCurrent
64011-601-28640110601281 BOX in 1 BOX (64011-601-28) > 28 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK1 box2017-07-240000-00-00NoNoCurrent