FDA.reportPublic FDA data

Mefloquine Hydrochloride

Product NDC
50090-2396
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

Additional Listing Data#

Finished product
Yes
Brand name base
Mefloquine Hydrochloride
Listing expiration
2026-12-31

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
3f2d0ecd-4f7a-6e8c-a65e-58190a1c95dfProduct name220201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2396-02023-02-07C16284748780-1f386c64a-0eae-0266-e053-dadaa90a7c1aMefloquine Hydrochloride Tablets USP
50090-2396-12023-02-07C16284748780-1f386c64a-0eae-0266-e053-dadaa90a7c1aMefloquine Hydrochloride Tablets USP
50090-2396-22023-02-07C16284748780-1f386c64a-0eae-0266-e053-dadaa90a7c1aMefloquine Hydrochloride Tablets USP
50090-2396-02023-01-30C16284748780-1f386c64a-0eae-0266-e053-dadaa90a7c1aMefloquine Hydrochloride Tablets USP
50090-2396-12023-01-30C16284748780-1f386c64a-0eae-0266-e053-dadaa90a7c1aMefloquine Hydrochloride Tablets USP
50090-2396-22023-01-30C16284748780-1f386c64a-0eae-0266-e053-dadaa90a7c1aMefloquine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2396-0Mefloquine Hydrochloride1 in 1 CARTONTABLET112
50090-2396-0Mefloquine Hydrochloride10 in 1 BLISTER PACKTABLET1012
50090-2396-1Mefloquine Hydrochloride25 in 1 BLISTER PACKTABLET2512
50090-2396-1Mefloquine Hydrochloride1 in 1 CARTONTABLET112
50090-2396-2Mefloquine Hydrochloride8 in 1 BLISTER PACKTABLET812
50090-2396-2Mefloquine Hydrochloride1 in 1 CARTONTABLET112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2396-0EA - Each50090-239644b8f77b-3e18-4e6d-83ab-4919cb07ebee12019-02-13
50090-2396-2EA - Each50090-2396582c7120-3476-4855-b733-d772c1df763912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2396MEFLOQUINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 6 package rows20250406_9cbe26c7-7313-4cd6-9514-9190af1de763.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835913mefloquine HCl 250 MG Oral TabletPSN9cbe26c7-7313-4cd6-9514-9190af1de76312
835913mefloquine hydrochloride 250 MG Oral TabletSCD9cbe26c7-7313-4cd6-9514-9190af1de76312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2396-0500902396001 BLISTER PACK in 1 CARTON (50090-2396-0) / 10 TABLET in 1 BLISTER PACK1 blister pack2016-05-060000-00-00NoNoCurrent
50090-2396-1500902396011 BLISTER PACK in 1 CARTON (50090-2396-1) > 25 TABLET in 1 BLISTER PACK1 blister pack2016-05-060000-00-00NoNoCurrent
50090-2396-2500902396021 BLISTER PACK in 1 CARTON (50090-2396-2) > 8 TABLET in 1 BLISTER PACK1 blister pack2016-05-060000-00-00NoNoCurrent