MebendamaX

Product NDC
55758-441
11-digit product format
557580441
Labeler code
55758
Product ID
55758-441_37db6b69-9455-c41c-e063-6294a90ae3ee
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrantel Pamoate
Dosage form
TABLET
Route
ORAL
Labeler
Pharmadel LLC
Application
M024
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-01
Substance
PYRANTEL PAMOATE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MebendamaX
Brand name suffix
Pinworm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRANTEL PAMOATE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii81BK194Z5M
Rxcui199107

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-441-10MebendamaXPinworm10 in 1 CARTONTABLET102
55758-441-10MebendamaXPinworm1 in 1 BLISTER PACKTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-441MEBENDAMAX PINWORM (PYRANTEL PAMOATE) TABLET [PHARMADEL LLC]1Current NDC, 2 package rows20240802_1d75b912-3550-7d4c-e063-6294a90ad5fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199107pyrantel pamoate 180 MG Oral TabletPSN1d75b912-3550-7d4c-e063-6294a90ad5fa2
199107pyrantel 180 MG Oral TabletSCD1d75b912-3550-7d4c-e063-6294a90ad5fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-441-105575804411010 BLISTER PACK in 1 CARTON (55758-441-10) / 1 TABLET in 1 BLISTER PACK10 blister pack2024-08-01NoNoHistorical