NDC 61919-706

ISENTRESS

Isentress

ISENTRESS is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Raltegravir Potassium.

Product ID61919-706_442d9e67-1c2d-73f8-e054-00144ff8d46c
NDC61919-706
Product TypeHuman Prescription Drug
Proprietary NameISENTRESS
Generic NameIsentress
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-12-21
Marketing CategoryNDA / NDA
Application NumberNDA022145
Labeler NameDIRECT RX
Substance NameRALTEGRAVIR POTASSIUM
Active Ingredient Strength400 mg/1
Pharm ClassesHIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-706-02

2 TABLET, FILM COATED in 1 BOTTLE (61919-706-02)
Marketing Start Date2019-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-706-04 [61919070604]

ISENTRESS TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-21
Inactivation Date2020-01-31

NDC 61919-706-02 [61919070602]

ISENTRESS TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022145
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-13

Drug Details

Active Ingredients

IngredientStrength
RALTEGRAVIR POTASSIUM400 mg/1

OpenFDA Data

SPL SET ID:442d9e67-1c2c-73f8-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 744842

    • Pharmacological Class

    • HIV Integrase Inhibitors [MoA]
    • Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]

    NDC Crossover Matching brand name "ISENTRESS" or generic name "Isentress"

    NDCBrand NameGeneric Name
    0006-0227ISENTRESSRALTEGRAVIR
    0006-0473ISENTRESSRALTEGRAVIR
    0006-0477ISENTRESSRALTEGRAVIR
    0006-3080ISENTRESSRALTEGRAVIR
    0006-3603ISENTRESSRALTEGRAVIR
    50090-1085ISENTRESSRALTEGRAVIR
    53808-0650ISENTRESSraltegravir
    61919-706ISENTRESSISENTRESS
    66336-214ISENTRESSRALTEGRAVIR
    67296-1235ISENTRESSISENTRESS
    68071-2113ISENTRESSRALTEGRAVIR
    70518-1621ISENTRESSISENTRESS
    76519-1130ISENTRESSISENTRESS

    Trademark Results [ISENTRESS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ISENTRESS
    ISENTRESS
    78866853 3357758 Live/Registered
    MERCK SHARP & DOHME CORP.
    2006-04-21
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