FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
21695-692
11-digit product format
216950692
Labeler code
21695
Product ID
21695-692_4f359545-2248-4f13-9651-c2aad0153ee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA073192
Marketing category
ANDA
Marketing start
1992-04-30
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-692-102019-09-24C16284748780-1934fe258-4770-48b1-e053-8cdaa90a720aLOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311
21695-692-122019-09-24C16284748780-1934fe258-4770-48b1-e053-8cdaa90a720aLOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311
21695-692-152019-09-24C16284748780-1934fe258-4770-48b1-e053-8cdaa90a720aLOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-692-10Loperamide Hydrochloride10 in 1 BOTTLECAPSULE102
21695-692-12Loperamide Hydrochloride12 in 1 BOTTLECAPSULE122
21695-692-15Loperamide Hydrochloride15 in 1 BOTTLECAPSULE152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-692-10EA - Each21695-692d8f5f4d1-8180-491d-92e1-749cb4bb50d212012-07-24
21695-692-12EA - Each21695-6924404c17b-64db-4aba-97a0-e93b4fe2d98212012-07-24
21695-692-15EA - Each21695-6925269a007-8c66-4e98-a923-823a0beca14a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Loperamide HydrochlorideACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
LoperamideACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
GELATININACTIVE INGREDIENT2G86QN327LLOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
IRONINACTIVE INGREDIENTE1UOL152H7LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-692LOPERAMIDE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 3 package rows20111021_5c2f4b11-6c45-4270-9b0b-ce73d5eae65f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN5c2f4b11-6c45-4270-9b0b-ce73d5eae65f2
978006loperamide hydrochloride 2 MG Oral CapsuleSCD5c2f4b11-6c45-4270-9b0b-ce73d5eae65f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-692-102169506921010 in 1 BOTTLEHistorical
21695-692-122169506921212 in 1 BOTTLEHistorical
21695-692-152169506921515 in 1 BOTTLEHistorical