atovaquone

Generic: atovaquone

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atovaquone 750 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-528
Product ID 62135-528_19392345-2a5f-cbf6-e063-6394a90a61f1
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 62135528
Hyphenated Format 62135-528

Supplemental Identifiers

RxCUI
308429
UPC
0362135528096
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
  • 210 mL in 1 BOTTLE (62135-528-09)
  • 2 TRAY in 1 BOX (62135-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-528-45)
source: ndc

Packages (2)

62135-528-09 210 mL in 1 BOTTLE (62135-528-09) 62135-528-24 2 TRAY in 1 BOX (62135-528-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-528-45)

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": "19392345-2a5f-cbf6-e063-6394a90a61f1", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0362135528096"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["de0e29b5-a4c7-405c-a5b9-438729d9ba3a"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "210 mL in 1 BOTTLE (62135-528-09)", "package_ndc": "62135-528-09", "marketing_start_date": "20230718"}, {"sample": false, "description": "2 TRAY in 1 BOX (62135-528-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-528-45)", "package_ndc": "62135-528-24", "marketing_start_date": "20240523"}], "brand_name": "Atovaquone", "product_id": "62135-528_19392345-2a5f-cbf6-e063-6394a90a61f1", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "62135-528", "generic_name": "Atovaquone", "labeler_name": "Chartwell 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"}