malarone

Generic: atovaquone and proguanil hydrochloride

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name malarone
Generic Name atovaquone and proguanil hydrochloride
Labeler glaxosmithkline llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atovaquone 62.5 mg/1, proguanil hydrochloride 25 mg/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0676
Product ID 0173-0676_6bbf5863-1ec0-412d-834d-33704359bac4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021078
Listing Expiration 2026-12-31
Marketing Start 2000-07-26

Pharmacologic Class

Established (EPC)
antimalarial [epc] antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730676
Hyphenated Format 0173-0676

Supplemental Identifiers

RxCUI
864675 864679 864681 864685
UPC
0301730676016 0301730675019
UNII
Y883P1Z2LT R71Y86M0WT
NUI
N0000175482 N0000175485

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 malarone (source: ndc)
Generic Name atovaquone and proguanil hydrochloride (source: ndc)
Application Number NDA021078 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 62.5 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01)
source: ndc

Packages (1)

0173-0676-01 100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01)

Ingredients (2)

atovaquone (62.5 mg/1) proguanil hydrochloride (25 mg/1)

Linked Drug Pages (1)

MALARONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6bbf5863-1ec0-412d-834d-33704359bac4", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0301730676016", "0301730675019"], "unii": ["Y883P1Z2LT", "R71Y86M0WT"], "rxcui": ["864675", "864679", "864681", "864685"], "spl_set_id": ["fc22e8d8-3bfb-4f70-a599-dd81262a4887"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01)", "package_ndc": "0173-0676-01", "marketing_start_date": "20000726"}], "brand_name": "MALARONE", "product_id": "0173-0676_6bbf5863-1ec0-412d-834d-33704359bac4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antimalarial [EPC]", "Antiprotozoal [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "0173-0676", "generic_name": "atovaquone and proguanil hydrochloride", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MALARONE", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "62.5 mg/1"}, {"name": "PROGUANIL HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "NDA021078", "marketing_category": "NDA", "marketing_start_date": "20000726", "listing_expiration_date": "20261231"}