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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-973-11Mefloquine Hydrochloride5 in 1 BOTTLETABLET51
62135-973-25Mefloquine Hydrochloride25 in 1 BOTTLETABLET251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-973-25EA - Each62135-97397f89896-7870-4144-b402-dd64a55a7ac612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-973MEFLOQUINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]1Current NDC, 2 package rows20241120_b884d22b-aae7-4f14-9a04-ae4029a229f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835913mefloquine HCl 250 MG Oral TabletPSNb884d22b-aae7-4f14-9a04-ae4029a229f01
835913mefloquine hydrochloride 250 MG Oral TabletSCDb884d22b-aae7-4f14-9a04-ae4029a229f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-973-11621350973115 TABLET in 1 BOTTLE (62135-973-11) 5 tablet2024-11-15NoNoHistorical
62135-973-256213509732525 TABLET in 1 BOTTLE (62135-973-25) 25 tablet2024-11-15NoNoHistorical