atovaquone

Generic: atovaquone

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atovaquone
Generic Name atovaquone
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

atovaquone 750 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-528
Product ID 68999-528_430808cb-6a2f-94ee-e063-6394a90ab6fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207833
Listing Expiration 2026-12-31
Marketing Start 2017-04-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68999528
Hyphenated Format 68999-528

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 ANDA207833 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-528-45)
source: ndc

Packages (1)

68999-528-24 2 TRAY in 1 BOX (68999-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-528-45)

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": "430808cb-6a2f-94ee-e063-6394a90ab6fd", "openfda": {"nui": ["N0000175482", "N0000175485"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["e6770b85-54f8-4969-af02-7d81586be761"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-528-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-528-45)", "package_ndc": "68999-528-24", "marketing_start_date": "20251025"}], "brand_name": "Atovaquone", "product_id": "68999-528_430808cb-6a2f-94ee-e063-6394a90ab6fd", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "68999-528", "generic_name": "Atovaquone", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atovaquone", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "750 mg/5mL"}], "application_number": "ANDA207833", "marketing_category": "ANDA", "marketing_start_date": "20170428", "listing_expiration_date": "20261231"}