isentress

Generic: raltegravir

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name isentress
Generic Name raltegravir
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

raltegravir potassium 400 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2113
Product ID 68071-2113_1d749c51-f082-f9d5-e063-6394a90a4d8f
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 680712113
Hyphenated Format 68071-2113

Supplemental Identifiers

RxCUI
744842 744846
UPC
0368071211368
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
  • 6 TABLET, FILM COATED in 1 BOTTLE (68071-2113-6)
source: ndc

Packages (1)

68071-2113-6 6 TABLET, FILM COATED in 1 BOTTLE (68071-2113-6)

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": "1d749c51-f082-f9d5-e063-6394a90a4d8f", "openfda": {"upc": ["0368071211368"], "unii": ["43Y000U234"], "rxcui": ["744842", "744846"], "spl_set_id": ["46ef8e2e-ae63-6a3c-e054-00144ff8d46c"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (68071-2113-6)", "package_ndc": "68071-2113-6", "marketing_start_date": "20170125"}], "brand_name": "ISENTRESS", "product_id": "68071-2113_1d749c51-f082-f9d5-e063-6394a90a4d8f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HIV Integrase Inhibitors [MoA]", "Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]"], "product_ndc": "68071-2113", "generic_name": "RALTEGRAVIR", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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"}