atovaquone

Generic: atovaquone

Labeler: kesin pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atovaquone
Generic Name atovaquone
Labeler kesin pharma
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

atovaquone 750 mg/5mL

Manufacturer
Kesin Pharma

Identifiers & Regulatory

Product NDC 81033-104
Product ID 81033-104_3edaf9cd-76b2-a531-e063-6294a90a7e1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212918
Listing Expiration 2026-12-31
Marketing Start 2024-06-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81033104
Hyphenated Format 81033-104

Supplemental Identifiers

RxCUI
308429
UNII
Y883P1Z2LT
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 (source: ndc)
Generic Name atovaquone (source: ndc)
Application Number ANDA212918 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/5mL
source: ndc
Packaging
  • 20 CUP, UNIT-DOSE in 1 CARTON (81033-104-22) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)
  • 42 CUP, UNIT-DOSE in 1 CARTON (81033-104-42) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)
  • 50 CUP, UNIT-DOSE in 1 CARTON (81033-104-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)
source: ndc

Packages (3)

81033-104-22 20 CUP, UNIT-DOSE in 1 CARTON (81033-104-22) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05) 81033-104-42 42 CUP, UNIT-DOSE in 1 CARTON (81033-104-42) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05) 81033-104-50 50 CUP, UNIT-DOSE in 1 CARTON (81033-104-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)

Ingredients (1)

atovaquone (750 mg/5mL)

Linked Drug Pages (1)

Atovaquone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3edaf9cd-76b2-a531-e063-6294a90a7e1a", "openfda": {"nui": ["N0000175482", "N0000175485"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["16b69156-e5de-c601-e063-6394a90afeae"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Kesin Pharma"]}, "finished": true, "packaging": [{"sample": false, "description": "20 CUP, UNIT-DOSE in 1 CARTON (81033-104-22)  / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)", "package_ndc": "81033-104-22", "marketing_start_date": "20250915"}, {"sample": false, "description": "42 CUP, UNIT-DOSE in 1 CARTON (81033-104-42)  / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)", "package_ndc": "81033-104-42", "marketing_start_date": "20240617"}, {"sample": false, "description": "50 CUP, UNIT-DOSE in 1 CARTON (81033-104-50)  / 5 mL in 1 CUP, UNIT-DOSE (81033-104-05)", "package_ndc": "81033-104-50", "marketing_start_date": "20240617"}], "brand_name": "Atovaquone", "product_id": "81033-104_3edaf9cd-76b2-a531-e063-6294a90a7e1a", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "81033-104", "generic_name": "Atovaquone", "labeler_name": "Kesin Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atovaquone", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "750 mg/5mL"}], "application_number": "ANDA212918", "marketing_category": "ANDA", "marketing_start_date": "20240617", "listing_expiration_date": "20261231"}