atovaquone and proguanil hydrochloride

Generic: atovaquone and proguanil hydrochloride

Labeler: golden state medical supply, inc.
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 golden state medical supply, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-869
Product ID 51407-869_45b153c9-e06e-468c-e063-6294a90a2938
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202362
Listing Expiration 2026-12-31
Marketing Start 2014-05-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51407869
Hyphenated Format 51407-869

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 hydrochloride (source: ndc)
Generic Name atovaquone and proguanil hydrochloride (source: ndc)
Application Number ANDA202362 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-01)
  • 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-24)
source: ndc

Packages (2)

51407-869-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-01) 51407-869-24 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-24)

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": "45b153c9-e06e-468c-e063-6294a90a2938", "openfda": {"nui": ["N0000175482", "N0000175485"], "unii": ["Y883P1Z2LT", "R71Y86M0WT"], "rxcui": ["864675"], "spl_set_id": ["152433eb-1341-9cc0-e063-6394a90a1481"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-01)", "package_ndc": "51407-869-01", "marketing_start_date": "20240402"}, {"sample": false, "description": "24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-24)", "package_ndc": "51407-869-24", "marketing_start_date": "20240402"}], "brand_name": "Atovaquone and Proguanil Hydrochloride", "product_id": "51407-869_45b153c9-e06e-468c-e063-6294a90a2938", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antimalarial [EPC]", "Antiprotozoal [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "51407-869", "generic_name": "atovaquone and proguanil hydrochloride", "labeler_name": "Golden State Medical Supply, Inc.", "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": "ANDA202362", "marketing_category": "ANDA", "marketing_start_date": "20140527", "listing_expiration_date": "20261231"}