Home NDC 0173-0665 MEPRON
Product NDC 0173-0665
11-digit product format 001730665
Labeler code 0173
Product ID 0173-0665_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 1995-02-28
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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020500-001 MEPRON 750MG/5ML SUSPENSION / ORAL AB RLD, RS 1995-02-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 0173-0665-18 MEPRON 210 mL in 1 BOTTLE SUSPENSION 210 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0173-0665 MEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC] 25 Current NDC, Legacy NDC, 1 package rows 20240711_b426b6bf-f07e-4580-97ae-dfca1ddf5b8f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 0173-0665-18 00173066518 210 mL in 1 BOTTLE (0173-0665-18) 210 ml 1995-02-28 0000-00-00 No No Current