FDA.reportPublic FDA data

ISENTRESS

Product NDC
68071-2113
11-digit product format
680712113
Labeler code
68071
Product ID
68071-2113_1d749c51-f082-f9d5-e063-6394a90a4d8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RALTEGRAVIR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA022145
Marketing category
NDA
Marketing start
2007-10-12
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
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 POTASSIUM400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43Y000U234
Rxcui744842, 744846

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
68071-2113-62021-02-23C16284748780-1ba0f9c33-10f8-a910-e053-dadaa90a0b85These 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 ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007
68071-2113-62021-01-29C16284748780-1ba0f9c33-10f8-a910-e053-dadaa90a0b85These 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 ISENTRESS ® (raltegravir) for oral suspension Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2113-6ISENTRESS6 in 1 BOTTLETABLET, FILM COATED67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2113ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 1 package rows20240719_46ef8e2e-ae63-6a3c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
744846Isentress 400 MG Oral TabletPSN46ef8e2e-ae63-6a3c-e054-00144ff8d46c7
744842raltegravir 400 MG Oral TabletPSN46ef8e2e-ae63-6a3c-e054-00144ff8d46c7
744846raltegravir 400 MG Oral Tablet [Isentress]SBD46ef8e2e-ae63-6a3c-e054-00144ff8d46c7
744842raltegravir 400 MG Oral TabletSCD46ef8e2e-ae63-6a3c-e054-00144ff8d46c7
744846ISENTRESS 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY46ef8e2e-ae63-6a3c-e054-00144ff8d46c7
744846ISENTRESS 400 MG Oral TabletSY46ef8e2e-ae63-6a3c-e054-00144ff8d46c7
744842raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY46ef8e2e-ae63-6a3c-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2113-6680712113066 TABLET, FILM COATED in 1 BOTTLE (68071-2113-6) 2017-01-250000-00-00NoNoCurrent