Loperamide Hydrochloride

Product NDC
50090-6208
11-digit product format
500906208
Labeler code
50090
Product ID
50090-6208_78dbd61f-4c6d-4982-931c-9c74a5be2078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215001
Marketing category
ANDA
Marketing start
2020-09-25
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
50090-6208-02024-01-30C16284748780-11030e365-46e4-111a-e063-dadaa90a10e2Loperamide Hydrochloride
50090-6208-32024-01-30C16284748780-11030e365-46e4-111a-e063-dadaa90a10e2Loperamide Hydrochloride
50090-6208-42024-01-30C16284748780-11030e365-46e4-111a-e063-dadaa90a10e2Loperamide Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6208-0Loperamide Hydrochloride15 in 1 BOTTLECAPSULE151
50090-6208-3Loperamide Hydrochloride12 in 1 BOTTLECAPSULE121
50090-6208-4Loperamide Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6208-0EA - Each50090-620833d16262-fa63-4e7c-bf40-bded4510dfd812022-12-07
50090-6208-3EA - Each50090-620814c22ed3-299d-437c-a055-2bb4ac26539f12022-12-07
50090-6208-4EA - Each50090-620883f1c6b7-912a-4b0c-aedd-972d135fc2c712022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6208LOPERAMIDE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 3 package rows20221109_619c6d6a-7eca-4f89-9913-d4e9388515fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN619c6d6a-7eca-4f89-9913-d4e9388515fa1
978006loperamide hydrochloride 2 MG Oral CapsuleSCD619c6d6a-7eca-4f89-9913-d4e9388515fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6208-05009062080015 CAPSULE in 1 BOTTLE (50090-6208-0) 15 capsule2022-11-070000-00-00NoNoCurrent
50090-6208-35009062080312 CAPSULE in 1 BOTTLE (50090-6208-3) 12 capsule2022-11-070000-00-00NoNoCurrent
50090-6208-45009062080430 CAPSULE in 1 BOTTLE (50090-6208-4) 30 capsule2022-11-070000-00-00NoNoCurrent