ISENTRESS

Product NDC
67296-1235
11-digit product format
672961235
Labeler code
67296
Product ID
67296-1235_d61018ec-f0b9-36df-e053-2995a90a0b29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISENTRESS
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA022145
Marketing category
NDA
Marketing start
2007-10-12
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1235-6ISENTRESS6 in 1 BOTTLETABLET, FILM COATED65
67296-1235-7ISENTRESS56 in 1 BOTTLETABLET, FILM COATED565
67296-1235-8ISENTRESS8 in 1 BOTTLETABLET, FILM COATED85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1235ISENTRESS TABLET, FILM COATED [REDPHARM DRUG, INC.]5Legacy NDC, 3 package rows20240716_4f31df66-7dc7-1f04-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
744842raltegravir 400 MG Oral TabletPSN4f31df66-7dc7-1f04-e054-00144ff88e885
744842raltegravir 400 MG Oral TabletSCD4f31df66-7dc7-1f04-e054-00144ff88e885
744842raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY4f31df66-7dc7-1f04-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1235-6672961235066 TABLET, FILM COATED in 1 BOTTLE (67296-1235-6) 2007-10-120000-00-00NoNoCurrent
67296-1235-76729612350756 in 1 BOTTLEHistorical
67296-1235-8672961235088 TABLET, FILM COATED in 1 BOTTLE (67296-1235-8) 2007-10-120000-00-00NoNoCurrent