atovaquone

Generic: atovaquone

Labeler: abon pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atovaquone
Generic Name atovaquone
Labeler abon pharmaceuticals, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

atovaquone 750 mg/5mL

Manufacturer
Abon Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 42239-001
Product ID 42239-001_34f67d35-7080-d493-e063-6294a90a5cc9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214272
Listing Expiration 2026-12-31
Marketing Start 2023-11-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42239001
Hyphenated Format 42239-001

Supplemental Identifiers

RxCUI
308429
UNII
Y883P1Z2LT
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 (source: ndc)
Generic Name atovaquone (source: ndc)
Application Number ANDA214272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42239-001-08) / 210 mL in 1 BOTTLE
  • 6 CUP, UNIT-DOSE in 1 TRAY (42239-001-66) / 5 mL in 1 CUP, UNIT-DOSE (42239-001-17)
source: ndc

Packages (2)

42239-001-08 1 BOTTLE in 1 CARTON (42239-001-08) / 210 mL in 1 BOTTLE 42239-001-66 6 CUP, UNIT-DOSE in 1 TRAY (42239-001-66) / 5 mL in 1 CUP, UNIT-DOSE (42239-001-17)

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": "34f67d35-7080-d493-e063-6294a90a5cc9", "openfda": {"nui": ["N0000175482", "N0000175485"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd08"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Abon Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42239-001-08)  / 210 mL in 1 BOTTLE", "package_ndc": "42239-001-08", "marketing_start_date": "20231114"}, {"sample": false, "description": "6 CUP, UNIT-DOSE in 1 TRAY (42239-001-66)  / 5 mL in 1 CUP, UNIT-DOSE (42239-001-17)", "package_ndc": "42239-001-66", "marketing_start_date": "20250501"}], "brand_name": "Atovaquone", "product_id": "42239-001_34f67d35-7080-d493-e063-6294a90a5cc9", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "42239-001", "generic_name": "Atovaquone", "labeler_name": "Abon Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atovaquone", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "750 mg/5mL"}], "application_number": "ANDA214272", "marketing_category": "ANDA", "marketing_start_date": "20231114", "listing_expiration_date": "20261231"}