NDC 0006-3603-01 - ISENTRESS

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0006-3603
Requested NDC
0006-3603-01
Package NDCs from labels
0006-3603-01, 0006-3603-60, 0006-3603-61
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2024-10-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ISENTRESS - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2024-10-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3603-01ISENTRESS1 in 1 PACKETGRANULE, FOR SUSPENSION170
0006-3603-60ISENTRESS60 in 1 CARTONGRANULE, FOR SUSPENSION6070
0006-3603-61ISENTRESS60 in 1 CARTONGRANULE, FOR SUSPENSION6070

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3603ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC]69Current NDC, Legacy NDC, 3 package rows20241030_89a5ec53-d956-4329-8004-0f40f51c88a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3603-01EA - Each0006-36032377cc21-50a6-4e45-b8f4-e530e7016b0812015-12-02
0006-3603-60EA - Each0006-36033524abee-3ba7-4a61-9580-961e4bae0def12014-07-02
0006-3603-61EA - Each0006-3603d1737108-20d4-43b3-9a26-27412e79d68b12018-02-20

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 131 · 2,612 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
Kroger Anti Nausea Cherry FlavorDEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACIDKROGER COMPANYfb7326db-3512-45ee-9a9b-48f3ebd8d0c52026-09-02WarningsExact identifier
unii: 6YSS42VSEV
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.