Home NDC 50090-2396-2 Mefloquine Hydrochloride
Product NDC 50090-2396
Requested package NDC 50090-2396-2
11-digit product format 500902396
Labeler code 50090
Product ID 50090-2396_4c4467e1-5886-4b66-aaff-8647a8591fce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mefloquine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA076392
Marketing category ANDA
Marketing start 2004-01-06
Substance MEFLOQUINE HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Antimalarial [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-2396 50090-2396-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-2396 50090-2396-2 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076392-001 MEFLOQUINE HYDROCHLORIDE MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076392-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL RS 2003-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076392-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB RS 2003-12-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mefloquine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEFLOQUINE HYDROCHLORIDE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5Y9L3636O3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 835913 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2396-0 Mefloquine Hydrochloride 1 in 1 CARTON TABLET 1 12 50090-2396-0 Mefloquine Hydrochloride 10 in 1 BLISTER PACK TABLET 10 12 50090-2396-1 Mefloquine Hydrochloride 25 in 1 BLISTER PACK TABLET 25 12 50090-2396-1 Mefloquine Hydrochloride 1 in 1 CARTON TABLET 1 12 50090-2396-2 Mefloquine Hydrochloride 8 in 1 BLISTER PACK TABLET 8 12 50090-2396-2 Mefloquine Hydrochloride 1 in 1 CARTON TABLET 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2396 MEFLOQUINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] 12 Current NDC, Legacy NDC, 6 package rows 20250406_9cbe26c7-7313-4cd6-9514-9190af1de763.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 · 2 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 50090-2396-2 50090239602 1 BLISTER PACK in 1 CARTON (50090-2396-2) > 8 TABLET in 1 BLISTER PACK 1 blister pack 2016-05-06 0000-00-00 No No Current