atovaquone

Generic: atovaquone

Labeler: lohxa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atovaquone 750 mg/5mL

Manufacturer
Lohxa

Identifiers & Regulatory

Product NDC 70166-488
Product ID 70166-488_30ca1c6b-6bc5-3dba-e063-6394a90a5656
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210692
Listing Expiration 2026-12-31
Marketing Start 2018-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70166488
Hyphenated Format 70166-488

Supplemental Identifiers

RxCUI
308429
UPC
0370166488050
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 ANDA210692 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/5mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Atovaquone oral suspension, USP is a yellow homogenous suspension containing 750 mg atovaquone USP per 5 mL. • 5mL UNIT DOSE CUPS, 50 UNITS IN 1 CARTON(NDC 70166-488-05). 5mL UNIT DOSE SYRINGE, 30 UNITS IN 1 CARTON(NDC 70166-488-10) Store at 15° to 25°C (59° to 77°F). Do not freeze . Dispense in tight container as defined in USP.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Atovaquone Oral Suspension, USP 750 mg/5 mL Carton Label atovaquoneoscartonlabel
source: label

Packages (0)

No package records.

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": "30ca1c6b-6bc5-3dba-e063-6394a90a5656", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0370166488050"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["ba3cad0d-cce9-424f-ba5c-557dba8bef12"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Lohxa"]}, "finished": true, "packaging": [], "brand_name": "Atovaquone", "product_id": "70166-488_30ca1c6b-6bc5-3dba-e063-6394a90a5656", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "70166-488", "generic_name": "Atovaquone", "labeler_name": "Lohxa", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atovaquone", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "750 mg/5mL"}], "application_number": "ANDA210692", "marketing_category": "ANDA", "marketing_start_date": "20181011", "listing_expiration_date": "20261231"}