FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii5Y9L3636O3
Rxcui835913

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

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