FDA.reportPublic FDA data

ISENTRESS

Product NDC
0006-0477
11-digit product format
000060477
Labeler code
0006
Product ID
0006-0477_70b9b593-db43-43ad-8808-a1c86c048145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RALTEGRAVIR
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA203045
Marketing category
NDA
Marketing start
2011-12-21
Substance
RALTEGRAVIR POTASSIUM
Active strength
100 mg/1
Pharmacologic classes
HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ISENTRESS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RALTEGRAVIR POTASSIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43Y000U234
Rxcui744842, 744846, 1235588, 1235591, 1235593, 1235595, 1486838, 1486841, 1924313, 1924315

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0477-61ISENTRESS60 in 1 BOTTLETABLET, CHEWABLE6070

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0477-61EA - Each0006-04771feeedfb-904c-43d6-84a6-de27a293a88312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RALTEGRAVIR POTASSIUMACTIVE INGREDIENT43Y000U234ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
RALTEGRAVIRACTIVE MOIETY22VKV8053UISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
AMMONIAINACTIVE INGREDIENT5138Q19F1XISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
CROSPOVIDONEINACTIVE INGREDIENT68401960MKISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
ETHYLCELLULOSE (20 MPA.S)INACTIVE INGREDIENTBJG0S321QYISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
MANNITOLINACTIVE INGREDIENT3OWL53L36AISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
SORBITOLINACTIVE INGREDIENT506T60A25RISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
SUCROSEINACTIVE INGREDIENTC151H8M554ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
TALCINACTIVE INGREDIENT7SEV7J4R1UISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME CORP.]49

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0477ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC]69Current NDC, Legacy NDC, 1 package rows20241030_89a5ec53-d956-4329-8004-0f40f51c88a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235591Isentress 100 MG Chewable TabletPSN89a5ec53-d956-4329-8004-0f40f51c88a370
1486841Isentress 100 MG Granules for Oral SuspensionPSN89a5ec53-d956-4329-8004-0f40f51c88a370
1235595Isentress 25 MG Chewable TabletPSN89a5ec53-d956-4329-8004-0f40f51c88a370
744846Isentress 400 MG Oral TabletPSN89a5ec53-d956-4329-8004-0f40f51c88a370
1924315Isentress 600 MG Oral TabletPSN89a5ec53-d956-4329-8004-0f40f51c88a370
1235588raltegravir 100 MG Chewable TabletPSN89a5ec53-d956-4329-8004-0f40f51c88a370
1486838raltegravir 100 MG Granules for Oral SuspensionPSN89a5ec53-d956-4329-8004-0f40f51c88a370
1235593raltegravir 25 MG Chewable TabletPSN89a5ec53-d956-4329-8004-0f40f51c88a370
744842raltegravir 400 MG Oral TabletPSN89a5ec53-d956-4329-8004-0f40f51c88a370
1924313raltegravir 600 MG Oral TabletPSN89a5ec53-d956-4329-8004-0f40f51c88a370
1235591raltegravir 100 MG Chewable Tablet [Isentress]SBD89a5ec53-d956-4329-8004-0f40f51c88a370
1486841raltegravir 100 MG Granules for Oral Suspension [Isentress]SBD89a5ec53-d956-4329-8004-0f40f51c88a370
1235595raltegravir 25 MG Chewable Tablet [Isentress]SBD89a5ec53-d956-4329-8004-0f40f51c88a370
744846raltegravir 400 MG Oral Tablet [Isentress]SBD89a5ec53-d956-4329-8004-0f40f51c88a370
1924315raltegravir 600 MG Oral Tablet [Isentress]SBD89a5ec53-d956-4329-8004-0f40f51c88a370
1235588raltegravir 100 MG Chewable TabletSCD89a5ec53-d956-4329-8004-0f40f51c88a370
1486838raltegravir 100 MG Granules for Oral SuspensionSCD89a5ec53-d956-4329-8004-0f40f51c88a370
1235593raltegravir 25 MG Chewable TabletSCD89a5ec53-d956-4329-8004-0f40f51c88a370
744842raltegravir 400 MG Oral TabletSCD89a5ec53-d956-4329-8004-0f40f51c88a370
1924313raltegravir 600 MG Oral TabletSCD89a5ec53-d956-4329-8004-0f40f51c88a370
1486841Isentress (raltegravir 100 MG (as raltegravir potassium 108.8 MG)) Granules for Oral SuspensionSY89a5ec53-d956-4329-8004-0f40f51c88a370
1235591ISENTRESS 100 MG (raltegravir potassium 108.6 MG) Chewable TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1235591ISENTRESS 100 MG Chewable TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1486841Isentress 100 MG Granules for Oral SuspensionSY89a5ec53-d956-4329-8004-0f40f51c88a370
1235595ISENTRESS 25 MG (raltegravir potassium 27.16 MG) Chewable TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1235595ISENTRESS 25 MG Chewable TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
744846ISENTRESS 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
744846ISENTRESS 400 MG Oral TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1924315Isentress 600 MG (as raltegravir potassium 651.6 MG) Oral TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1924315Isentress 600 MG Oral TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1235588raltegravir (as raltegravir potassium) 100 MG Chewable TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1235593raltegravir (as raltegravir potassium) 25 MG Chewable TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1486838raltegravir 100 MG (as raltegravir potassium 108.8 MG) Granules for Oral SuspensionSY89a5ec53-d956-4329-8004-0f40f51c88a370
744842raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370
1924313raltegravir 600 MG (as raltegravir potassium 651.6 MG) Oral TabletSY89a5ec53-d956-4329-8004-0f40f51c88a370

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0006-0477-610000604776160 TABLET, CHEWABLE in 1 BOTTLE (0006-0477-61) 2011-12-210000-00-00NoNoCurrent