FDA.reportPublic FDA data

ISENTRESS

Product NDC
71205-777
11-digit product format
712050777
Labeler code
71205
Product ID
71205-777_4cb3ef64-0fec-45c7-9c7f-5cca90c7a517
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RALTEGRAVIR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-777-06ISENTRESS6 in 1 BOTTLETABLET, FILM COATED62
71205-777-14ISENTRESS14 in 1 BOTTLETABLET, FILM COATED142
71205-777-30ISENTRESS30 in 1 BOTTLETABLET, FILM COATED302
71205-777-60ISENTRESS60 in 1 BOTTLETABLET, FILM COATED602
71205-777-90ISENTRESS90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-777ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, 5 package rows20241010_ccc6f2f9-696f-4ef9-bb4c-e0198d957b0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
744846Isentress 400 MG Oral TabletPSNccc6f2f9-696f-4ef9-bb4c-e0198d957b0b2
744842raltegravir 400 MG Oral TabletPSNccc6f2f9-696f-4ef9-bb4c-e0198d957b0b2
744846raltegravir 400 MG Oral Tablet [Isentress]SBDccc6f2f9-696f-4ef9-bb4c-e0198d957b0b2
744842raltegravir 400 MG Oral TabletSCDccc6f2f9-696f-4ef9-bb4c-e0198d957b0b2
744846ISENTRESS 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSYccc6f2f9-696f-4ef9-bb4c-e0198d957b0b2
744846ISENTRESS 400 MG Oral TabletSYccc6f2f9-696f-4ef9-bb4c-e0198d957b0b2
744842raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSYccc6f2f9-696f-4ef9-bb4c-e0198d957b0b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-777-06712050777066 TABLET, FILM COATED in 1 BOTTLE (71205-777-06) 2024-10-03NoNoCurrent
71205-777-147120507771414 TABLET, FILM COATED in 1 BOTTLE (71205-777-14) 2023-03-15NoNoCurrent
71205-777-307120507773030 TABLET, FILM COATED in 1 BOTTLE (71205-777-30) 2023-03-15NoNoCurrent
71205-777-607120507776060 TABLET, FILM COATED in 1 BOTTLE (71205-777-60) 2023-03-15NoNoCurrent
71205-777-907120507779090 TABLET, FILM COATED in 1 BOTTLE (71205-777-90) 2023-03-15NoNoCurrent