Mefloquine Hydrochloride

Product NDC
0143-1282
11-digit product format
001431282
Labeler code
0143
Product ID
0143-1282_9aaaf269-6535-48d6-be86-eb30c2732a86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mefloquine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp
Application
ANDA077699
Marketing category
ANDA
Marketing start
2010-04-21
Marketing end
0000-00-00
Substance
MEFLOQUINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Antimalarial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0143-1282DDiscontinued by firm2026-10-05
excluded packagepackage0143-12820143-1282-22DDiscontinued by firm2026-10-05

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-1282-22d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-1282-22f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-1282-222ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-1282-22a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-1282-22cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-1282-22cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-1282-22302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-1282-22ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-1282-220efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-1282-22ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-1282-22367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-1282-22557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077699-001MEFLOQUINE HYDROCHLORIDEMEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-2184e616aacf4f…
2026-08-18 06:07:402026-07A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-213f01610625f2…
2019-09-15 20:21 UTC2019-09A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3f2d0ecd-4f7a-6e8c-a65e-58190a1c95dfProduct name220201015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1282-22EA - Each0143-1282c26fc6cd-84e7-452a-bae6-e5d7b6cbf29f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEFLOQUINE HYDROCHLORIDEACTIVE INGREDIENT5Y9L3636O3MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MEFLOQUINE HYDROCHLORIDEACTIVE INGREDIENT5Y9L3636O3MEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
MEFLOQUINEACTIVE MOIETYTML814419RMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MEFLOQUINEACTIVE MOIETYTML814419RMEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEFLOQUINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835913mefloquine HCl 250 MG Oral TabletPSNb6ccbb82-3804-4f02-bf17-f07e22a8b02a1
835913mefloquine HCl 250 MG Oral TabletPSNe4ed49c5-2a8b-4d2b-b8fb-a69a556a48cc1
835913mefloquine hydrochloride 250 MG Oral TabletSCDb6ccbb82-3804-4f02-bf17-f07e22a8b02a1
835913mefloquine hydrochloride 250 MG Oral TabletSCDe4ed49c5-2a8b-4d2b-b8fb-a69a556a48cc1