Loperamide Hydrochloride

Product NDC
67296-0129
11-digit product format
672960129
Labeler code
67296
Product ID
67296-0129_3fc80822-6257-4937-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA072741
Marketing category
ANDA
Marketing start
2016-04-13
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
2018-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0129-12020-01-31C16284748780-19d75b9d1-114c-f424-e053-dadaa90a57ce3fc80822-6256-4937-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0129-1Loperamide Hydrochloride15 in 1 BOTTLECAPSULE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0129LOPERAMIDE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]1Legacy NDC, 1 package rows20161026_3fc80822-6256-4937-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN3fc80822-6256-4937-e054-00144ff8d46c1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3fc80822-6256-4937-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0129-16729601290115 in 1 BOTTLEHistorical