Loperamide Hydrochloride

Product NDC
55154-5585
11-digit product format
551545585
Labeler code
55154
Product ID
55154-5585_5aa9dc53-a7fc-4c35-b481-079ef5905bb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA072741
Marketing category
ANDA
Marketing start
1997-03-10
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978006

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-5585-0Loperamide Hydrochloride1 in 1 BLISTER PACKCAPSULE112
55154-5585-0Loperamide Hydrochloride10 in 1 BAGCAPSULE1012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
GELATININACTIVE INGREDIENT2G86QN327LLOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5585LOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 2 package rows20240605_be99224e-dd49-4628-a5bf-ed8469ffd4a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNbe99224e-dd49-4628-a5bf-ed8469ffd4a412
978006loperamide hydrochloride 2 MG Oral CapsuleSCDbe99224e-dd49-4628-a5bf-ed8469ffd4a412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5585-05515455850010 BLISTER PACK in 1 BAG (55154-5585-0) / 1 CAPSULE in 1 BLISTER PACK10 blister pack1997-03-100000-00-00NoNoCurrent