FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
67046-456
11-digit product format
670460456
Labeler code
67046
Product ID
67046-456_7df01850-e7c5-8a5a-e053-2a91aa0a7886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA072741
Marketing category
ANDA
Marketing start
2017-09-20
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
2020-12-31
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
67046-456-072022-01-28C16284748780-1d6a99b39-9e0a-a426-e053-dadaa90af4c2Loperamide 2 mg 456
67046-456-142022-01-28C16284748780-1d6a99b39-9e0a-a426-e053-dadaa90af4c2Loperamide 2 mg 456
67046-456-152022-01-28C16284748780-1d6a99b39-9e0a-a426-e053-dadaa90af4c2Loperamide 2 mg 456
67046-456-202022-01-28C16284748780-1d6a99b39-9e0a-a426-e053-dadaa90af4c2Loperamide 2 mg 456
67046-456-212022-01-28C16284748780-1d6a99b39-9e0a-a426-e053-dadaa90af4c2Loperamide 2 mg 456
67046-456-282022-01-28C16284748780-1d6a99b39-9e0a-a426-e053-dadaa90af4c2Loperamide 2 mg 456
67046-456-302022-01-28C16284748780-1d6a99b39-9e0a-a426-e053-dadaa90af4c2Loperamide 2 mg 456
67046-456-602022-01-28C16284748780-1d6a99b39-9e0a-a426-e053-dadaa90af4c2Loperamide 2 mg 456

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-456-07Loperamide Hydrochloride7 in 1 BLISTER PACKCAPSULE72
67046-456-14Loperamide Hydrochloride14 in 1 BLISTER PACKCAPSULE142
67046-456-15Loperamide Hydrochloride15 in 1 BLISTER PACKCAPSULE152
67046-456-20Loperamide Hydrochloride20 in 1 BLISTER PACKCAPSULE202
67046-456-21Loperamide Hydrochloride21 in 1 BLISTER PACKCAPSULE212
67046-456-28Loperamide Hydrochloride28 in 1 BLISTER PACKCAPSULE282
67046-456-30Loperamide Hydrochloride30 in 1 BLISTER PACKCAPSULE302
67046-456-60Loperamide Hydrochloride60 in 1 BLISTER PACKCAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-456LOPERAMIDE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 8 package rows20181227_59a44282-30f2-103b-e053-2a91aa0a643a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN59a44282-30f2-103b-e053-2a91aa0a643a2
978006loperamide hydrochloride 2 MG Oral CapsuleSCD59a44282-30f2-103b-e053-2a91aa0a643a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-456-07670460456077 CAPSULE in 1 BLISTER PACK (67046-456-07) 7 capsule2017-09-200000-00-00NoNoCurrent
67046-456-146704604561414 CAPSULE in 1 BLISTER PACK (67046-456-14) 14 capsule2017-09-200000-00-00NoNoCurrent
67046-456-156704604561515 CAPSULE in 1 BLISTER PACK (67046-456-15) 15 capsule2017-09-200000-00-00NoNoCurrent
67046-456-206704604562020 CAPSULE in 1 BLISTER PACK (67046-456-20) 20 capsule2017-09-200000-00-00NoNoCurrent
67046-456-216704604562121 CAPSULE in 1 BLISTER PACK (67046-456-21) 21 capsule2017-09-200000-00-00NoNoCurrent
67046-456-286704604562828 CAPSULE in 1 BLISTER PACK (67046-456-28) 28 capsule2017-09-200000-00-00NoNoCurrent
67046-456-306704604563030 CAPSULE in 1 BLISTER PACK (67046-456-30) 30 capsule2017-09-200000-00-00NoNoCurrent
67046-456-606704604566060 CAPSULE in 1 BLISTER PACK (67046-456-60) 60 capsule2017-09-200000-00-00NoNoCurrent