Loperamide Hydrochloride

Product NDC
68071-2863
11-digit product format
680712863
Labeler code
68071
Product ID
68071-2863_ebf2b303-6368-a27f-e053-2995a90a5a35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA215579
Marketing category
ANDA
Marketing start
2021-12-01
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
68071-2863-42025-01-30C16284748780-12cef2736-a8fe-d83d-e063-dadaa90ab31fLoperamide Hydrochloride Capsules, USP Rx only
68071-2863-62025-01-30C16284748780-12cef2736-a8fe-d83d-e063-dadaa90ab31fLoperamide Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2863-4Loperamide Hydrochloride4 in 1 BOTTLE, PLASTICCAPSULE42
68071-2863-6Loperamide Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2863LOPERAMIDE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230919_ebf2b8c1-dba6-12ba-e053-2995a90a4a4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNebf2b8c1-dba6-12ba-e053-2995a90a4a4f2
978006loperamide hydrochloride 2 MG Oral CapsuleSCDebf2b8c1-dba6-12ba-e053-2995a90a4a4f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2863-4680712863044 CAPSULE in 1 BOTTLE, PLASTIC (68071-2863-4) 4 capsule2022-10-260000-00-00NoNoCurrent
68071-2863-66807128630660 in 1 BOTTLE, PLASTICHistorical