FDA.reportPublic FDA data

ISENTRESS

Product NDC
50090-1085
11-digit product format
500901085
Labeler code
50090
Product ID
50090-1085_fa8200b3-64ad-4ba4-a708-7a9b564d2ac8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RALTEGRAVIR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-1085-0ISENTRESS60 in 1 BOTTLETABLET, FILM COATED6025
50090-1085-1ISENTRESS8 in 1 BOTTLETABLET, FILM COATED825
50090-1085-2ISENTRESS6 in 1 BOTTLETABLET, FILM COATED625

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1085-0EA - Each50090-1085a72fbd5e-077b-4fac-8c29-e7b31c49f8a012018-11-06
50090-1085-1EA - Each50090-108563c2d802-1ea0-460d-bcd5-b69a69b66bcf12018-11-06
50090-1085-2EA - Each50090-1085ad6c3bd1-230b-4829-a1c0-a0ca4254847c12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1085ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 3 package rows20231210_7e659505-c902-4906-9461-1cc83e2236d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
744846Isentress 400 MG Oral TabletPSN7e659505-c902-4906-9461-1cc83e2236d225
744842raltegravir 400 MG Oral TabletPSN7e659505-c902-4906-9461-1cc83e2236d225
744846raltegravir 400 MG Oral Tablet [Isentress]SBD7e659505-c902-4906-9461-1cc83e2236d225
744842raltegravir 400 MG Oral TabletSCD7e659505-c902-4906-9461-1cc83e2236d225
744846ISENTRESS 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY7e659505-c902-4906-9461-1cc83e2236d225
744846ISENTRESS 400 MG Oral TabletSY7e659505-c902-4906-9461-1cc83e2236d225
744842raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral TabletSY7e659505-c902-4906-9461-1cc83e2236d225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1085-05009010850060 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0) 2014-11-280000-00-00NoNoCurrent
50090-1085-1500901085018 TABLET, FILM COATED in 1 BOTTLE (50090-1085-1) 2014-11-280000-00-00NoNoCurrent
50090-1085-2500901085026 TABLET, FILM COATED in 1 BOTTLE (50090-1085-2) 2018-03-160000-00-00NoNoCurrent