isentress

Generic: raltegravir

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name isentress
Generic Name raltegravir
Labeler merck sharp & dohme llc
Dosage Form GRANULE, FOR SUSPENSION
Routes
ORAL
Active Ingredients

raltegravir potassium 100 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-3603
Product ID 0006-3603_70b9b593-db43-43ad-8808-a1c86c048145
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205786
Listing Expiration 2026-12-31
Marketing Start 2013-12-20

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 00063603
Hyphenated Format 0006-3603

Supplemental Identifiers

RxCUI
744842 744846 1235588 1235591 1235593 1235595 1486838 1486841 1924313 1924315
UPC
0300060227615 0300060473616 0300063080019
UNII
43Y000U234

Packaging Origin

Original Packager
true

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 NDA205786 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 PACKET in 1 CARTON (0006-3603-60) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)
  • 60 PACKET in 1 CARTON (0006-3603-61) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)
source: ndc

Packages (2)

0006-3603-60 60 PACKET in 1 CARTON (0006-3603-60) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01) 0006-3603-61 60 PACKET in 1 CARTON (0006-3603-61) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)

Ingredients (1)

raltegravir potassium (100 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": "70b9b593-db43-43ad-8808-a1c86c048145", "openfda": {"upc": ["0300060227615", "0300060473616", "0300063080019"], "unii": ["43Y000U234"], "rxcui": ["744842", "744846", "1235588", "1235591", "1235593", "1235595", "1486838", "1486841", "1924313", "1924315"], "spl_set_id": ["89a5ec53-d956-4329-8004-0f40f51c88a3"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 PACKET in 1 CARTON (0006-3603-60)  / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)", "package_ndc": "0006-3603-60", "marketing_start_date": "20131220"}, {"sample": false, "description": "60 PACKET in 1 CARTON (0006-3603-61)  / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)", "package_ndc": "0006-3603-61", "marketing_start_date": "20171122"}], "brand_name": "ISENTRESS", "product_id": "0006-3603_70b9b593-db43-43ad-8808-a1c86c048145", "dosage_form": "GRANULE, FOR SUSPENSION", "pharm_class": ["HIV Integrase Inhibitors [MoA]", "Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]"], "product_ndc": "0006-3603", "generic_name": "RALTEGRAVIR", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISENTRESS", "active_ingredients": [{"name": "RALTEGRAVIR POTASSIUM", "strength": "100 mg/1"}], "application_number": "NDA205786", "marketing_category": "NDA", "marketing_start_date": "20131220", "listing_expiration_date": "20261231"}