Home NDC 66993-062 Atovaquone
Product NDC 66993-062
11-digit product format 669930062
Labeler code 66993
Product ID 66993-062_58b0ae61-aff1-4cec-bf03-eba8b8569a71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atovaquone
Dosage form SUSPENSION
Route ORAL
Labeler Prasco Laboratories
Application NDA020500
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-03-20
Marketing end 2020-09-30
Substance ATOVAQUONE
Active strength 750 mg/5mL
Pharmacologic classes Antimalarial [EPC],Antiprotozoal [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020500-001 MEPRON ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020500-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N020500-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MEPRON ATOVAQUONE GlaxoSmithKline LLC b426b6bf-f07e-4580-97ae-dfca1ddf5b8f 2026-03-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 020500 application number: NDA020500
DailyMed Socrata Ingredients#