Mefloquine Hydrochloride

Product NDC
0555-0171
11-digit product format
005550171
Labeler code
0555
Product ID
0555-0171_4b2b45f8-ed63-4b3c-87c5-801996f5b154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mefloquine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076392-001MEFLOQUINE HYDROCHLORIDEMEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076392-001AB

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 22:38:342026-08A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-2984e616aacf4f…
2026-08-18 06:07:402026-07A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALRS2003-12-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALRS2003-12-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALRS2003-12-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALRS2003-12-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-293f01610625f2…
2019-09-15 20:21 UTC2019-09A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076392-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORALABRS2003-12-29f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076392-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A076392-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076392-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076392-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076392-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076392-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076392-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076392-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076392-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076392-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076392-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076392-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076392-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076392-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076392-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076392-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076392-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076392-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076392-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076392-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076392-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076392-001AB1782e0a99824c…
2019-12-14 00:12 UTC2019-12A076392-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076392-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076392-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076392-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076392-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076392-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076392-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076392-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076392-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076392-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076392-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076392-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076392-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076392-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076392-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076392-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076392-001AB1a50c72e98297…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEFLOQUINE HYDROCHLORIDE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5Y9L3636O3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
835913Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
09716a24-d7da-42b2-af29-c03a1b6670bdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3f2d0ecd-4f7a-6e8c-a65e-58190a1c95dfProduct name220201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-0171-78Mefloquine Hydrochloride25 in 1 CARTONTABLET2513
0555-0171-88Mefloquine Hydrochloride1 in 1 BLISTER PACKTABLET113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0171-78EA - Each0555-0171ced7dc8e-758c-47ca-ac2b-21fa9628223212012-07-24
0555-0171-88EA - Each0555-0171f76a7449-141c-4758-955d-97f282c401fd12017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEFLOQUINE HYDROCHLORIDEACTIVE INGREDIENT5Y9L3636O3MEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
mefloquineACTIVE MOIETYTML814419RMEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGMEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMEFLOQUINE HYDROCHLORIDE TABLET [BARR LABORATORIES INC.]5
mefloquine hydrochlorideACTIVE INGREDIENT5Y9L3636O3MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
mefloquineACTIVE MOIETYTML814419RMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
magnesium stearateINACTIVE INGREDIENT70097M6I30MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
POLOXAMER 124INACTIVE INGREDIENT1S66E28KXAMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2
talcINACTIVE INGREDIENT7SEV7J4R1UMEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0171MEFLOQUINE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 2 package rows20230217_09716a24-d7da-42b2-af29-c03a1b6670bd.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mefloquine HydrochlorideMEFLOQUINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.09716a24-d7da-42b2-af29-c03a1b6670bd2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076392
application number: ANDA076392
ndc (product): 0555-0171
Mefloquine HydrochlorideMEFLOQUINE HYDROCHLORIDEA-S Medication Solutions9cbe26c7-7313-4cd6-9514-9190af1de7632025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076392
application number: ANDA076392

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835913mefloquine HCl 250 MG Oral TabletPSN09716a24-d7da-42b2-af29-c03a1b6670bd13
835913mefloquine hydrochloride 250 MG Oral TabletSCD09716a24-d7da-42b2-af29-c03a1b6670bd13
835913mefloquine HCl 250 MG Oral TabletPSN9cbe26c7-7313-4cd6-9514-9190af1de76312
835913mefloquine hydrochloride 250 MG Oral TabletSCD9cbe26c7-7313-4cd6-9514-9190af1de76312
835913mefloquine HCl 250 MG Oral TabletPSN57ca7bc4-e1a4-4a09-82bd-8b455e5ec3e42
835913mefloquine hydrochloride 250 MG Oral TabletSCD57ca7bc4-e1a4-4a09-82bd-8b455e5ec3e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0171-780055501717825 BLISTER PACK in 1 CARTON (0555-0171-78) / 1 TABLET in 1 BLISTER PACK (0555-0171-88) 25 blister pack2004-01-060000-00-00NoNoCurrent
0555-0171-88005550171881 in 1 BLISTER PACKHistorical