isentress

Generic: raltegravir

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name isentress
Generic Name raltegravir
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

raltegravir potassium 400 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1085
Product ID 50090-1085_fa8200b3-64ad-4ba4-a708-7a9b564d2ac8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022145
Listing Expiration 2026-12-31
Marketing Start 2007-10-12

Pharmacologic Class

Classes
hiv integrase inhibitors [moa] human immunodeficiency virus integrase strand transfer inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500901085
Hyphenated Format 50090-1085

Supplemental Identifiers

RxCUI
744842 744846
UNII
43Y000U234

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name isentress (source: ndc)
Generic Name raltegravir (source: ndc)
Application Number NDA022145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0)
source: ndc

Packages (1)

50090-1085-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0)

Ingredients (1)

raltegravir potassium (400 mg/1)

Linked Drug Pages (1)

ISENTRESS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fa8200b3-64ad-4ba4-a708-7a9b564d2ac8", "openfda": {"unii": ["43Y000U234"], "rxcui": ["744842", "744846"], "spl_set_id": ["7e659505-c902-4906-9461-1cc83e2236d2"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0)", "package_ndc": "50090-1085-0", "marketing_start_date": "20141128"}], "brand_name": "ISENTRESS", "product_id": "50090-1085_fa8200b3-64ad-4ba4-a708-7a9b564d2ac8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HIV Integrase Inhibitors [MoA]", "Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]"], "product_ndc": "50090-1085", "generic_name": "RALTEGRAVIR", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISENTRESS", "active_ingredients": [{"name": "RALTEGRAVIR POTASSIUM", "strength": "400 mg/1"}], "application_number": "NDA022145", "marketing_category": "NDA", "marketing_start_date": "20071012", "listing_expiration_date": "20261231"}