FDA.reportPublic FDA data

ISENTRESS

Product NDC
61919-706
11-digit product format
619190706
Labeler code
61919
Product ID
61919-706_d5e239df-4a66-354f-e053-2995a90a1a57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISENTRESS
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
NDA022145
Marketing category
NDA
Marketing start
2016-12-21
Marketing end
0000-00-00
Substance
RALTEGRAVIR POTASSIUM
Active strength
400 mg/1
Pharmacologic classes
HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
323837e1-94ea-4944-ae44-aa6cc9ccda3bProduct name220260223
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c873f14e-2add-4d53-b9b3-bf775efd3702Product name120150325
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-706-022025-01-30C16284748780-12cef2736-5df6-d83d-e063-dadaa90ab31fISENTRESS
61919-706-042025-01-30C16284748780-19d75b9d0-192a-f424-e053-dadaa90a57ceISENTRESS
61919-706-062025-01-30C16284748780-19d75b9d0-192a-f424-e053-dadaa90a57ceISENTRESS
61919-706-042021-01-12C16284748780-19d75b9d0-192a-f424-e053-dadaa90a57ceISENTRESS
61919-706-042020-01-31C16284748780-19d75b9d0-192a-f424-e053-dadaa90a57ceISENTRESS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-706-02ISENTRESS2 in 1 BOTTLETABLET, FILM COATED23
61919-706-04ISENTRESS4 in 1 BOTTLETABLET, FILM COATED43
61919-706-06ISENTRESS6 in 1 BOTTLETABLET, FILM COATED63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-706-02EA - Each61919-7068756dbff-4c22-4ef2-b9e9-b68ea85e4c9812019-09-05
61919-706-06EA - Each61919-706ca624b2c-cd0b-4168-ba61-e91d2aaf13cb12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-706ISENTRESS TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 2 package rows20220119_442d9e67-1c2c-73f8-e054-00144ff8d46c.zip
61919-706ISENTRESS TABLET, FILM COATED [DIRECT_RX]3Legacy NDC, 1 package rows20210113_9000a7ea-efce-3fba-e053-2a95a90ae2c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
744842raltegravir 400 MG Oral TabletPSN442d9e67-1c2c-73f8-e054-00144ff8d46c3
744842raltegravir 400 MG Oral TabletPSN9000a7ea-efce-3fba-e053-2a95a90ae2c33
744842raltegravir 400 MG Oral TabletSCD442d9e67-1c2c-73f8-e054-00144ff8d46c3
744842raltegravir 400 MG Oral TabletSCD9000a7ea-efce-3fba-e053-2a95a90ae2c33
744842raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY442d9e67-1c2c-73f8-e054-00144ff8d46c3
744842raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY9000a7ea-efce-3fba-e053-2a95a90ae2c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-706-02619190706022 TABLET, FILM COATED in 1 BOTTLE (61919-706-02) 2019-08-130000-00-00NoNoCurrent
61919-706-04619190706044 TABLET, FILM COATED in 1 BOTTLE (61919-706-04) 2016-12-210000-00-00NoNoCurrent
61919-706-06619190706066 TABLET, FILM COATED in 1 BOTTLE (61919-706-06) 2016-12-210000-00-00NoNoCurrent