FDA.reportPublic FDA data

Loperamide Hydrochloride

Product NDC
67046-454
11-digit product format
670460454
Labeler code
67046
Product ID
67046-454_59a421cf-dfab-6685-e053-2a91aa0a9b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA073192
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
2019-12-31
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
67046-454-072020-01-31C16284748780-19d75b9d0-3427-f424-e053-dadaa90a57ceLoperamide Hydrochloride Capsules USP 454 Rx only
67046-454-142020-01-31C16284748780-19d75b9d0-3427-f424-e053-dadaa90a57ceLoperamide Hydrochloride Capsules USP 454 Rx only
67046-454-152020-01-31C16284748780-19d75b9d0-3427-f424-e053-dadaa90a57ceLoperamide Hydrochloride Capsules USP 454 Rx only
67046-454-202020-01-31C16284748780-19d75b9d0-3427-f424-e053-dadaa90a57ceLoperamide Hydrochloride Capsules USP 454 Rx only
67046-454-212020-01-31C16284748780-19d75b9d0-3427-f424-e053-dadaa90a57ceLoperamide Hydrochloride Capsules USP 454 Rx only
67046-454-282020-01-31C16284748780-19d75b9d0-3427-f424-e053-dadaa90a57ceLoperamide Hydrochloride Capsules USP 454 Rx only
67046-454-302020-01-31C16284748780-19d75b9d0-3427-f424-e053-dadaa90a57ceLoperamide Hydrochloride Capsules USP 454 Rx only
67046-454-602020-01-31C16284748780-19d75b9d0-3427-f424-e053-dadaa90a57ceLoperamide Hydrochloride Capsules USP 454 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-454-07Loperamide Hydrochloride7 in 1 BLISTER PACKCAPSULE71
67046-454-14Loperamide Hydrochloride14 in 1 BLISTER PACKCAPSULE141
67046-454-15Loperamide Hydrochloride15 in 1 BLISTER PACKCAPSULE151
67046-454-20Loperamide Hydrochloride20 in 1 BLISTER PACKCAPSULE201
67046-454-21Loperamide Hydrochloride21 in 1 BLISTER PACKCAPSULE211
67046-454-28Loperamide Hydrochloride28 in 1 BLISTER PACKCAPSULE281
67046-454-30Loperamide Hydrochloride30 in 1 BLISTER PACKCAPSULE301
67046-454-60Loperamide Hydrochloride60 in 1 BLISTER PACKCAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-454LOPERAMIDE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170920_59a421cf-dfaa-6685-e053-2a91aa0a9b3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN59a421cf-dfaa-6685-e053-2a91aa0a9b3f1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD59a421cf-dfaa-6685-e053-2a91aa0a9b3f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-454-07670460454077 in 1 BLISTER PACKHistorical
67046-454-146704604541414 in 1 BLISTER PACKHistorical
67046-454-156704604541515 in 1 BLISTER PACKHistorical
67046-454-206704604542020 in 1 BLISTER PACKHistorical
67046-454-216704604542121 in 1 BLISTER PACKHistorical
67046-454-286704604542828 in 1 BLISTER PACKHistorical
67046-454-306704604543030 in 1 BLISTER PACKHistorical
67046-454-606704604546060 in 1 BLISTER PACKHistorical