Loperamide Hydrochloride

Product NDC
53808-0707
11-digit product format
538080707
Labeler code
53808
Product ID
53808-0707_de0592d5-7e0e-41bb-af4d-62d1bdddb668
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA073192
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
53808-0707-12020-01-31C16284748780-19d75b9cf-d53e-f424-e053-dadaa90a57ceLOPERAMIDE HYDROCHLORIDE CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0707-1Loperamide Hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0707LOPERAMIDE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100322_ab07bfd1-d2d3-427a-866d-89a10d40a4e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNab07bfd1-d2d3-427a-866d-89a10d40a4e92
978006loperamide hydrochloride 2 MG Oral CapsuleSCDab07bfd1-d2d3-427a-866d-89a10d40a4e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0707-15380807070130 in 1 BLISTER PACKHistorical