LOPERAMIDE HYDROCHLORIDE

Product NDC
61919-423
11-digit product format
619190423
Labeler code
61919
Product ID
61919-423_d9a2ee9a-d415-7cd1-e053-2a95a90a4442
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA073192
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-423-12LOPERAMIDE HYDROCHLORIDE12 in 1 BOTTLECAPSULE128
61919-423-20LOPERAMIDE HYDROCHLORIDE20 in 1 BOTTLECAPSULE208
61919-423-30LOPERAMIDE HYDROCHLORIDE30 in 1 BOTTLECAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-423-20EA - Each61919-423a0e99673-f0e6-498f-84f0-e0fa8fb3103b12022-04-06
61919-423-30EA - Each61919-423da5025e6-485b-4433-98ac-d17dc506f33312015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OLOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LLOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OLOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-423LOPERAMIDE HYDROCHLORIDE CAPSULE [DIRECT RX]8Legacy NDC, 3 package rows20230421_d358a9c1-47fa-424c-8cc0-24010cfb7ee3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNd358a9c1-47fa-424c-8cc0-24010cfb7ee38
978006loperamide hydrochloride 2 MG Oral CapsuleSCDd358a9c1-47fa-424c-8cc0-24010cfb7ee38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-423-126191904231212 CAPSULE in 1 BOTTLE (61919-423-12) 12 capsule2015-01-010000-00-00NoNoCurrent
61919-423-206191904232020 CAPSULE in 1 BOTTLE (61919-423-20) 20 capsule2014-01-010000-00-00NoNoCurrent
61919-423-306191904233030 CAPSULE in 1 BOTTLE (61919-423-30) 30 capsule2014-01-010000-00-00NoNoCurrent