atovaquone

Generic: atovaquone

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atovaquone
Generic Name atovaquone
Labeler american health packaging
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

atovaquone 750 mg/5mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-534
Product ID 60687-534_415fac59-7480-cad1-e063-6394a90ad7ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210692
Listing Expiration 2026-12-31
Marketing Start 2020-10-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687534
Hyphenated Format 60687-534

Supplemental Identifiers

RxCUI
308429
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
  • 2 TRAY in 1 CASE (60687-534-36) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-534-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40)
  • 7 TRAY in 1 CASE (60687-534-78) / 6 CUP, UNIT-DOSE in 1 TRAY (60687-534-52) / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40)
source: ndc

Packages (2)

60687-534-36 2 TRAY in 1 CASE (60687-534-36) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-534-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40) 60687-534-78 7 TRAY in 1 CASE (60687-534-78) / 6 CUP, UNIT-DOSE in 1 TRAY (60687-534-52) / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40)

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": "415fac59-7480-cad1-e063-6394a90ad7ba", "openfda": {"nui": ["N0000175482", "N0000175485"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["1a8a43a2-bc26-4ee5-aa35-22a5477a7129"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 CASE (60687-534-36)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-534-46)  / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40)", "package_ndc": "60687-534-36", "marketing_start_date": "20230713"}, {"sample": false, "description": "7 TRAY in 1 CASE (60687-534-78)  / 6 CUP, UNIT-DOSE in 1 TRAY (60687-534-52)  / 5 mL in 1 CUP, UNIT-DOSE (60687-534-40)", "package_ndc": "60687-534-78", "marketing_start_date": "20201021"}], "brand_name": "Atovaquone", "product_id": "60687-534_415fac59-7480-cad1-e063-6394a90ad7ba", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "60687-534", "generic_name": "Atovaquone", "labeler_name": "American Health Packaging", "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": "20201021", "listing_expiration_date": "20261231"}