atovaquone

Generic: atovaquone oral suspension

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atovaquone
Generic Name atovaquone oral suspension
Labeler major pharmaceuticals
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

atovaquone 750 mg/5mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7459
Product ID 0904-7459_9c1dfc30-52ac-4fec-a728-135917f39c1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214272
Listing Expiration 2026-12-31
Marketing Start 2024-07-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047459
Hyphenated Format 0904-7459

Supplemental Identifiers

RxCUI
308429
UPC
0309047459414
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 oral suspension (source: ndc)
Application Number ANDA214272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/5mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (0904-7459-25) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)
  • 7 TRAY in 1 CASE (0904-7459-53) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)
source: ndc

Packages (2)

0904-7459-25 3 TRAY in 1 CASE (0904-7459-25) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41) 0904-7459-53 7 TRAY in 1 CASE (0904-7459-53) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)

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": "9c1dfc30-52ac-4fec-a728-135917f39c1a", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0309047459414"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["73e2297e-7cda-4abf-9fb7-8c67cb5638a3"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (0904-7459-25)  / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)", "package_ndc": "0904-7459-25", "marketing_start_date": "20240708"}, {"sample": false, "description": "7 TRAY in 1 CASE (0904-7459-53)  / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7459-41)", "package_ndc": "0904-7459-53", "marketing_start_date": "20240708"}], "brand_name": "ATOVAQUONE", "product_id": "0904-7459_9c1dfc30-52ac-4fec-a728-135917f39c1a", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "0904-7459", "generic_name": "Atovaquone Oral Suspension", "labeler_name": "Major Pharmaceuticals", "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": "20240708", "listing_expiration_date": "20261231"}