Loperamide Hydrochloride

Product NDC
50090-2859
11-digit product format
500902859
Labeler code
50090
Product ID
50090-2859_054fc49e-3e45-47ad-8785-9a1cbb331f5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA072741
Marketing category
ANDA
Marketing start
1991-09-18
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
50090-2859-02020-01-31C16284748780-19d75b9d0-0c3a-f424-e053-dadaa90a57ce5dd31d61-7081-4895-8321-a77b439d7d2c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2859-0Loperamide Hydrochloride1 in 1 BLISTER PACKCAPSULE14
50090-2859-0Loperamide Hydrochloride33 in 1 BOX, UNIT-DOSECAPSULE334

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2859-0EA - Each50090-2859995489b5-8678-4ccd-9690-cc8a8cdabae112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2859LOPERAMIDE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20190115_5dd31d61-7081-4895-8321-a77b439d7d2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN5dd31d61-7081-4895-8321-a77b439d7d2c4
978006loperamide hydrochloride 2 MG Oral CapsuleSCD5dd31d61-7081-4895-8321-a77b439d7d2c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2859-0500902859001 in 1 BLISTER PACKHistorical