Home NDC 0121-1016 Atovaquone
Product NDC 0121-1016
11-digit product format 001211016
Labeler code 0121
Product ID 0121-1016_0145c97d-2d5e-4fcd-ae76-85e4ae946350
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atovaquone
Dosage form SUSPENSION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA214272
Marketing category ANDA
Marketing start 2024-01-10
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 A214272-001 ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214272-001 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 2026-08-18 06:07:40 2026-07 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214272-001 ATOVAQUONE 750MG/5ML SUSPENSION / ORAL AB 2021-10-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Atovaquone
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308429 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1016 ATOVAQUONE SUSPENSION [PAI HOLDINGS, LLC] 2 Current NDC, 5 package rows 20240215_2a7b2c9c-dbdd-41a8-a0eb-e3af4d8212be.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0121-1016-05 00121101605 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0121-1016-18 00121101618 3 TRAY in 1 CASE (0121-1016-18) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1016-05) 3 tray 2024-01-10 No No Current 0121-1016-42 00121101642 7 TRAY in 1 CASE (0121-1016-42) / 6 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1016-05) 7 tray 2024-01-10 No No Current