atovaquone and proguanil hcl

Generic: atovaquone and proguanil hydrochloride

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

Drug Facts

Product Profile

Brand Name atovaquone and proguanil hcl
Generic Name atovaquone and proguanil hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atovaquone 250 mg/1, proguanil hydrochloride 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-2980
Product ID 50090-2980_db61f577-1818-4643-8712-23db5c162ae6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021078
Listing Expiration 2026-12-31
Marketing Start 2012-07-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500902980
Hyphenated Format 50090-2980

Supplemental Identifiers

RxCUI
864675
UNII
Y883P1Z2LT R71Y86M0WT
NUI
N0000175482 N0000175485

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

Resolved Composition

Strengths
  • 250 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED in 1 BOTTLE (50090-2980-0)
  • 12 TABLET, FILM COATED in 1 BOTTLE (50090-2980-1)
  • 14 TABLET, FILM COATED in 1 BOTTLE (50090-2980-2)
  • 16 TABLET, FILM COATED in 1 BOTTLE (50090-2980-3)
  • 24 TABLET, FILM COATED in 1 BOTTLE (50090-2980-4)
  • 5 TABLET, FILM COATED in 1 BOTTLE (50090-2980-5)
  • 10 TABLET, FILM COATED in 1 BOTTLE (50090-2980-6)
  • 100 TABLET, FILM COATED in 1 BOTTLE (50090-2980-7)
  • 20 TABLET, FILM COATED in 1 BOTTLE (50090-2980-8)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-2980-9)
source: ndc

Packages (10)

Ingredients (2)

atovaquone (250 mg/1) proguanil hydrochloride (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "db61f577-1818-4643-8712-23db5c162ae6", "openfda": {"nui": ["N0000175482", "N0000175485"], "unii": ["Y883P1Z2LT", "R71Y86M0WT"], "rxcui": ["864675"], "spl_set_id": ["593baf3d-bd9e-4a44-8f90-125aa4a7a99e"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (50090-2980-0)", "package_ndc": "50090-2980-0", "marketing_start_date": "20170504"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (50090-2980-1)", "package_ndc": "50090-2980-1", "marketing_start_date": "20170427"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (50090-2980-2)", "package_ndc": "50090-2980-2", "marketing_start_date": "20170508"}, {"sample": false, "description": "16 TABLET, FILM COATED in 1 BOTTLE (50090-2980-3)", "package_ndc": "50090-2980-3", "marketing_start_date": "20170428"}, {"sample": false, "description": "24 TABLET, FILM COATED in 1 BOTTLE (50090-2980-4)", "package_ndc": "50090-2980-4", "marketing_start_date": "20170421"}, {"sample": false, "description": "5 TABLET, FILM COATED in 1 BOTTLE (50090-2980-5)", "package_ndc": "50090-2980-5", "marketing_start_date": "20170425"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (50090-2980-6)", "package_ndc": "50090-2980-6", "marketing_start_date": "20171116"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50090-2980-7)", "package_ndc": "50090-2980-7", "marketing_start_date": "20180117"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (50090-2980-8)", "package_ndc": "50090-2980-8", "marketing_start_date": "20180201"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-2980-9)", "package_ndc": "50090-2980-9", "marketing_start_date": "20180212"}], "brand_name": "Atovaquone and Proguanil HCl", "product_id": "50090-2980_db61f577-1818-4643-8712-23db5c162ae6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antimalarial [EPC]", "Antiprotozoal [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "50090-2980", "generic_name": "atovaquone and proguanil hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atovaquone and Proguanil HCl", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "250 mg/1"}, {"name": "PROGUANIL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "NDA021078", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20120727", "listing_expiration_date": "20261231"}