Loperamide Hydrochloride

Product NDC
67296-0346
11-digit product format
672960346
Labeler code
67296
Product ID
67296-0346_d5fc0481-fea4-a7bf-e053-2995a90a1620
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA073192
Marketing category
ANDA
Marketing start
2011-01-01
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0346-12024-06-19C16284748780-11030e365-26b2-111a-e063-dadaa90a10e23fcb106c-f72e-17d9-e054-00144ff8d46c
67296-0346-12024-01-30C16284748780-11030e365-26b2-111a-e063-dadaa90a10e23fcb106c-f72e-17d9-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0346-1Loperamide Hydrochloride15 in 1 BOTTLECAPSULE155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0346LOPERAMIDE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20240620_3fcb106c-f72e-17d9-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN3fcb106c-f72e-17d9-e054-00144ff8d46c5
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3fcb106c-f72e-17d9-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0346-16729603460115 CAPSULE in 1 BOTTLE (67296-0346-1) 15 capsule2011-01-010000-00-00NoNoCurrent