atovaquone

Generic: atovaquone

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atovaquone
Generic Name atovaquone
Labeler glenmark pharmaceuticals inc., usa
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

atovaquone 750 mg/5mL

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-421
Product ID 68462-421_9084fbfb-e877-45a3-9126-58a03737adf8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209685
Listing Expiration 2026-12-31
Marketing Start 2017-12-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462421
Hyphenated Format 68462-421

Supplemental Identifiers

RxCUI
308429
UPC
0368462421215
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 ANDA209685 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/5mL
source: ndc
Packaging
  • 210 mL in 1 BOTTLE (68462-421-21)
  • 42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCH
source: ndc

Packages (2)

68462-421-21 210 mL in 1 BOTTLE (68462-421-21) 68462-421-69 42 POUCH in 1 CARTON (68462-421-69) / 5 mL in 1 POUCH

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": "9084fbfb-e877-45a3-9126-58a03737adf8", "openfda": {"nui": ["N0000175482", "N0000175485"], "upc": ["0368462421215"], "unii": ["Y883P1Z2LT"], "rxcui": ["308429"], "spl_set_id": ["9045ba6f-938e-4717-bfa2-a3efe52f04cd"], "pharm_class_epc": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "210 mL in 1 BOTTLE (68462-421-21)", "package_ndc": "68462-421-21", "marketing_start_date": "20171231"}, {"sample": false, "description": "42 POUCH in 1 CARTON (68462-421-69)  / 5 mL in 1 POUCH", "package_ndc": "68462-421-69", "marketing_start_date": "20171231"}], "brand_name": "atovaquone", "product_id": "68462-421_9084fbfb-e877-45a3-9126-58a03737adf8", "dosage_form": "SUSPENSION", "pharm_class": ["Antimalarial [EPC]", "Antiprotozoal [EPC]"], "product_ndc": "68462-421", "generic_name": "atovaquone", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "atovaquone", "active_ingredients": [{"name": "ATOVAQUONE", "strength": "750 mg/5mL"}], "application_number": "ANDA209685", "marketing_category": "ANDA", "marketing_start_date": "20171231", "listing_expiration_date": "20261231"}