FDA.reportPublic FDA data

ISENTRESS

Product NDC
66336-214
11-digit product format
663360214
Labeler code
66336
Product ID
66336-214_cf313cc0-44c0-4f55-a021-8fab00af41ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RALTEGRAVIR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, 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
E
Listing certified through
2017-12-31
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
66336-214-062019-11-27C16284748780-19855d018-e78f-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ISENTRESS ® (raltegravir) Film-Coated Tablets, for oral use ISENTRESS ® (raltegravir) Chewable Tablets, for oral use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-214-06ISENTRESS6 in 1 BOTTLETABLET, FILM COATED62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-214-06EA - Each66336-214118538e2-b3ae-4c2b-b057-1eaf34fc7e0e12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RALTEGRAVIR POTASSIUMACTIVE INGREDIENT43Y000U234ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
RALTEGRAVIRACTIVE MOIETY22VKV8053UISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-214ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20130625_b05735be-d278-4c31-bfb5-ebf74ce42b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
744846Isentress 400 MG Oral TabletPSNb05735be-d278-4c31-bfb5-ebf74ce42b892
744842raltegravir 400 MG Oral TabletPSNb05735be-d278-4c31-bfb5-ebf74ce42b892
744846raltegravir 400 MG Oral Tablet [Isentress]SBDb05735be-d278-4c31-bfb5-ebf74ce42b892
744842raltegravir 400 MG Oral TabletSCDb05735be-d278-4c31-bfb5-ebf74ce42b892
744846ISENTRESS 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSYb05735be-d278-4c31-bfb5-ebf74ce42b892
744846ISENTRESS 400 MG Oral TabletSYb05735be-d278-4c31-bfb5-ebf74ce42b892
744842raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSYb05735be-d278-4c31-bfb5-ebf74ce42b892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-214-06663360214066 in 1 BOTTLEHistorical