Loperamide Hydrochloride

Product NDC
66336-046
11-digit product format
663360046
Labeler code
66336
Product ID
66336-046_f9d114cb-c8ad-4660-ba45-4c08e60839d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA073192
Marketing category
ANDA
Marketing start
2011-09-23
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-046-022019-11-27C16284748780-19855d018-e97e-cd31-e053-dbdaa90ab51aLOPERAMIDE HYDROCHLORIDE CAPSULES USP 0311 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-046-02Loperamide Hydrochloride2 in 1 BOTTLECAPSULE23

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-046LOPERAMIDE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 1 package rows20121004_3d23f73b-afc2-448d-afb3-b167d02cfc06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN3d23f73b-afc2-448d-afb3-b167d02cfc063
978006loperamide hydrochloride 2 MG Oral CapsuleSCD3d23f73b-afc2-448d-afb3-b167d02cfc063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-046-02663360046022 in 1 BOTTLEHistorical