Home NDC 0173-0547 MEPRON
Product NDC 0173-0547
11-digit product format 001730547
Labeler code 0173
Product ID 0173-0547_568047d4-1669-4c16-bbd0-d242a6b91507
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atovaquone
Dosage form SUSPENSION
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA020500
Marketing category NDA
Marketing start 1998-09-18
Substance ATOVAQUONE
Active strength 750 mg/5mL
Pharmacologic classes Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base MEPRON
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOVAQUONE 750 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y883P1Z2LT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 211947 Internal RxNorm lookup 308429 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0173-0547-00 MEPRON 42 in 1 DOSE PACK SUSPENSION 42 27 0173-0547-00 MEPRON 5 mL in 1 POUCH SUSPENSION 5 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0173-0547 MEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC] 25 Current NDC, Legacy NDC, 2 package rows 20240711_b426b6bf-f07e-4580-97ae-dfca1ddf5b8f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0173-0547-00 00173054700 42 POUCH in 1 DOSE PACK (0173-0547-00) / 5 mL in 1 POUCH 42 pouch 1998-09-18 0000-00-00 No No Current