atovaquone

Generic: atovaquone

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

Drug Facts

Product Profile

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

atovaquone 750 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-693
Product ID 65162-693_665b98de-365d-437b-bcf0-c0ba5cf791a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202960
Listing Expiration 2026-12-31
Marketing Start 2011-02-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162693
Hyphenated Format 65162-693

Supplemental Identifiers

RxCUI
308429
UPC
0365162693881
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 ANDA202960 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-693-88) / 210 mL in 1 BOTTLE
source: ndc

Packages (1)

65162-693-88 1 BOTTLE in 1 CARTON (65162-693-88) / 210 mL in 1 BOTTLE

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": "665b98de-365d-437b-bcf0-c0ba5cf791a9", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0365162693881"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["b7398fcf-522a-488a-8dd6-051561f62804"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-693-88)  / 210 mL in 1 BOTTLE", "package_ndc": "65162-693-88", "marketing_start_date": "20110209"}], "brand_name": "ATOVAQUONE", "product_id": "65162-693_665b98de-365d-437b-bcf0-c0ba5cf791a9", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "65162-693", "generic_name": "ATOVAQUONE", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATOVAQUONE", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "750 mg/5mL"}], "application_number": "ANDA202960", "marketing_category": "ANDA", "marketing_start_date": "20110209", "listing_expiration_date": "20261231"}