Home NDC 62135-973 Mefloquine Hydrochloride
Product NDC 62135-973
11-digit product format 621350973
Labeler code 62135
Product ID 62135-973_2732839a-191a-570f-e063-6294a90a40a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mefloquine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA076175
Marketing category ANDA
Marketing start 2022-02-20
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 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 A076175-001 MEFLOQUINE HYDROCHLORIDE MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB 2002-02-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076175-001 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 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB 2002-02-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB 2002-02-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB 2002-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB 2002-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL AB 2002-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076175-001 MEFLOQUINE HYDROCHLORIDE 250MG TABLET / ORAL 2002-02-20 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-973-11 Mefloquine Hydrochloride 5 in 1 BOTTLE TABLET 5 1 62135-973-25 Mefloquine Hydrochloride 25 in 1 BOTTLE TABLET 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-973 MEFLOQUINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC] 1 Current NDC, 2 package rows 20241120_b884d22b-aae7-4f14-9a04-ae4029a229f0.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 Sample Exclude flag Status 62135-973-11 62135097311 5 TABLET in 1 BOTTLE (62135-973-11) 5 tablet 2024-11-15 No No Current 62135-973-25 62135097325 25 TABLET in 1 BOTTLE (62135-973-25) 25 tablet 2024-11-15 No No Current