atovaquone and proguanil hydrochloride

Generic: atovaquone and proguanil hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atovaquone and proguanil hydrochloride
Generic Name atovaquone and proguanil hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-879
Product ID 63187-879_feeccc5c-a98f-4de7-b664-d450f77ee462
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091211
Listing Expiration 2026-12-31
Marketing Start 2011-08-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187879
Hyphenated Format 63187-879

Supplemental Identifiers

RxCUI
864675
UPC
0363187879242
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 hydrochloride (source: ndc)
Generic Name atovaquone and proguanil hydrochloride (source: ndc)
Application Number ANDA091211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 16 TABLET, FILM COATED in 1 BOTTLE (63187-879-16)
  • 24 TABLET, FILM COATED in 1 BOTTLE (63187-879-24)
source: ndc

Packages (2)

63187-879-16 16 TABLET, FILM COATED in 1 BOTTLE (63187-879-16) 63187-879-24 24 TABLET, FILM COATED in 1 BOTTLE (63187-879-24)

Ingredients (2)

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

Linked Drug Pages (1)

Atovaquone and Proguanil Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "feeccc5c-a98f-4de7-b664-d450f77ee462", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0363187879242"], "unii": ["Y883P1Z2LT", "R71Y86M0WT"], "rxcui": ["864675"], "spl_set_id": ["e74b00fc-8743-4e9d-8a83-aab8e531b3ba"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "16 TABLET, FILM COATED in 1 BOTTLE (63187-879-16)", "package_ndc": "63187-879-16", "marketing_start_date": "20240708"}, {"sample": false, "description": "24 TABLET, FILM COATED in 1 BOTTLE (63187-879-24)", "package_ndc": "63187-879-24", "marketing_start_date": "20170801"}], "brand_name": "Atovaquone and Proguanil Hydrochloride", "product_id": "63187-879_feeccc5c-a98f-4de7-b664-d450f77ee462", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antimalarial [EPC]", "Antiprotozoal [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "63187-879", "generic_name": "Atovaquone and Proguanil Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atovaquone and Proguanil Hydrochloride", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "250 mg/1"}, {"name": "PROGUANIL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA091211", "marketing_category": "ANDA", "marketing_start_date": "20110818", "listing_expiration_date": "20261231"}