atovaquone and proguanil hcl

Generic: atovaquone and proguanil hydrochloride

Labeler: prasco laboratories
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 prasco laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-060
Product ID 66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5
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 66993060
Hyphenated Format 66993-060

Supplemental Identifiers

RxCUI
864675
UPC
0366993060026
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 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
  • 100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02)
  • 24 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27)
source: ndc

Packages (2)

66993-060-02 100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02) 66993-060-27 24 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27)

Ingredients (2)

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

Linked Drug Pages (1)

Atovaquone and Proguanil HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e28a4ce-4524-4921-902c-7cc939eea6b5", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0366993060026"], "unii": ["Y883P1Z2LT", "R71Y86M0WT"], "rxcui": ["864675"], "spl_set_id": ["7069521a-c7f9-4e8d-99b8-0cb5c971e7cf"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02)", "package_ndc": "66993-060-02", "marketing_start_date": "20120727"}, {"sample": false, "description": "24 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27)", "package_ndc": "66993-060-27", "marketing_start_date": "20120727"}], "brand_name": "Atovaquone and Proguanil HCl", "product_id": "66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimalarial [EPC]", "Antimalarial [EPC]", "Antiprotozoal [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]"], "product_ndc": "66993-060", "generic_name": "atovaquone and proguanil hydrochloride", "labeler_name": "Prasco Laboratories", "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"}